The Associate Director of the IT Application Run Team will be responsible for leading and managing within assigned areas, ensure the stability, compliance, and performance of enterprise applications. Ensuring that operational processes and computerized systems deployed across IOPS meet the needs of the business and are compliant with relevant regulatory and security standards. Works with the equivalent Run Application Leads at other sites ensuring global alignment. As an Associate Director of the IT Application Run Team, a typical day might include the following: Oversee day-to-day IT application operations to ensure high service levels and SLAs are met (coverage may include application administration, minor enhancements, user support, application lifecycle, and system monitoring). Manage allocation of resources to support and maintain current applications. Establish and manage indicators of system health and performance. Ensure changes to applications and platform/OS updates are managed appropriately in collaboration with IOPS IT Operations and Corporate IT. Oversee third-party service providers (e.g., MSPs), ensuring performance and cost-effectiveness in partnership with other IT Run leads. Assist in annual IT budgeting, vendor negotiations, and resource allocation. Create and develop metrics with team leaders and utilize MDI structures to ensure optimal process and service performance. Maintain responsibility for system documentation ensuring accuracy and currency. Conduct risk assessments, audits, and implement disaster recovery and business continuity plans. Prepare the teams for regulatory and internal audits. Work with the validation and DI function to ensure systems remain in a compliant state. Proactively work with System Owners and end-users to ensure high levels of customer satisfaction. Establish communication forums with upper management and customers to provide ongoing and prompt status updates. Drive a continuous improvement mindset. Introduce process improvements and automation initiatives Ensure employee training requirements are met, development plans are in place, and performance management processes are adhered to. This Role May Be For You If: You are passionate about leading and developing teams, fostering growth, and driving performance. You thrive in environments where operational excellence and compliance are top priorities. You have a proven ability to manage resources, budgets, and vendor relationships effectively. You enjoy collaborating with cross-functional teams and engaging with stakeholders at all levels. You are driven to identify opportunities for process improvement and automation to enhance efficiency. You have a strong understanding of IT compliance guidelines, including PICS, CFR21 Part 11, Annex 11, and GAMP. You excel at balancing strategic planning with hands-on operational management. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field and 10 + years industry experience in Information Systems and Technology or equivalent combination of education and experience. 8 of those years should be in managing employees and budgets, with 7+ years of experience in a GMP manufacturing environment and experience in a biotech/pharma environment. Experience with IT Compliance guidelines including PICS, CFR21 Part 11, Annex 11 and GAMP preferred. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
The Senior Manager IT Applications - Run will oversee specific areas to ensure the stability, compliance, and performance of enterprise applications. Ensuring that operational processes and computerized systems deployed across IOPS meet the needs of the business and are compliant with relevant regulatory and security standards. Works with the equivalent Application Leads at other sites ensuring global alignment to provide high-quality support to System Owners and end-users, including user management, issue troubleshooting, training, and managing change requests. As a Senior Manager IT Applications - Run, a typical day might include the following: Lead and manage a team of full-time employees (FTEs) and contractors to deliver on end-user requirements effectively. Maintain accurate and up-to-date system documentation in compliance with organizational standards. Collaborate with the Validation Department to ensure applications remain in a validated state in accordance with IOPS SOPs. Partner with System Owners to prioritize change control requests and minor enhancements, ensuring timely execution. Drive operational rigor and discipline through the development and implementation of metrics, dashboards, and other operational controls. Communicate system operations and project status to executive stakeholders, ensuring alignment of resources with key priorities. Champion continuous improvement initiatives to enhance team performance, efficiency, and service delivery. Set annual team goals aligned with IT and IOPS objectives, leveraging MDI structures to monitor and manage progress. Manage application support staff, providing mentorship, coaching, and professional development opportunities. Ensure compliance with regulatory, corporate, and IOPS policies and procedures across the team. Collaborate with staff to define and achieve annual goals and objectives. Conduct monthly performance reviews and provide actionable feedback to drive individual and team success. This Role May Be For You If: You excel at managing IT applications and ensuring their compliance with regulatory standards. You enjoy providing high-quality support to end-users and System Owners, solving challenges with efficiency and attention to detail. You are passionate about mentoring and coaching team members to achieve their professional goals. You thrive in environments where operational rigor and performance metrics drive decision-making. You are committed to fostering a culture of continuous improvement and innovation. You have strong communication skills and are comfortable engaging with stakeholders at all levels. You bring a proactive, solutions-oriented mindset to managing change requests and enhancements. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field and 8+ years of relevant experience or equivalent combination of education and experience. 5+ of those years in managing systems. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. As we work across our growing global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we're establishing new ways to think about science, manufacturing and commercialization. We are looking for an experienced and motivated Regulatory Affairs Manager to join our team in either Dublin or London. In this pivotal role, you will bring your EU-specific regulatory expertise to support our development programs and ensure compliance with emerging EU legislation. This is a 12- month contract. A Typical Day: Develop and implement EU-appropriate regulatory strategies for clinical development and product approvals. Provide leadership on both late- and early-stage clinical development processes to ensure timely study conduct. Lead regulatory activities for clinical study start-up and maintenance, including submissions and addressing agency queries. Oversee Marketing Authorization Application (MAA) processes to secure timely product approvals with competitive labelling. Monitor and interpret emerging EU legislation and guidance, ensuring company-wide awareness and compliance. Serve as a key resource for EU regulatory knowledge to support global regulatory and development teams. This Role May Be For You If: You have a strong understanding of EU regulatory systems and processes. You excel at developing and executing regulatory strategies for clinical development. You are detail-oriented and adept at managing compliance issues and agency interactions. You enjoy collaborating with cross-functional teams and external collaborators. To Be Considered: You must hold an advanced degree in a scientific field (Master's Degree or Ph.D.) and have at least 5 years of experience in regulatory affairs. Experience with EU regulatory systems, clinical development processes, and working with EMA or EU National Agencies is important. Preferred applicants will have a strong background in respiratory or inflammation therapeutic areas and a proven ability to collaborate with business partners and cross-functional teams. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels. For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
The Senior Clinical Study Lead (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. This role is not eligible fully remote. This role is required to be onsite in one of our locations. A typical day in this role looks like: Leads the cross-functional study team responsible for clinical study delivery and is the primary point of contact of leadership and oversight (as required) for the assigned study Provides operational input into protocol development Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc. Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. Ensures compliance with the clinical trial registry requirements Identifies outsourcing needs of the study and leads and oversees engagement, contracting and management of required vendors Provides input into baseline budget development and management Provides input into baseline timeline development and management Leads risk assessment and identifies risk mitigation strategies at the study level Leads the feasibility assessment to select relevant regions and countries for the study Oversees/conducts site evaluation and selection Leads investigator meeting preparation and execution Monitors progress for site activation and monitoring visits and acts on any deviations from plan Leads the development of and oversees implementation of patient recruitment and retention strategies and acts on any deviations from plan Monitors data entry and query resolution and acts on any deviations from agreed metrics Ensures accurate budget management and scope changes for internal and external studies Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation Escalates issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other stakeholders and develops and implements appropriate actions to address issues Oversees the execution of the clinical study against planned timelines, deliverables and budget Oversees data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites Oversees and ensures the CROs and Third Party Vendors are in alignment and are delivering per the scope of work Ensure clinical project audit and inspection readiness through the study lifecycle Supports internal audit and external inspection activities and contributes to CAPAs as required Manages and oversees study close-out activities including but not limited to database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability Contributes to clinical study report writing and review Facilitates and contributes to study level lessons learned Assigns tasks to Clinical Study Management staff and supports their deliverables Recommends and participates in cross-functional and departmental process improvement initiatives Responsible for identification of innovative approaches to clinical study execution including global considerations and continuous improvement of CTM SOPs May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring Responsible for direct supervision of CTM staff. Line management responsibilities include work assignments, performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight May require 25% travel This role may be for you if you have: Exceptional interpersonal & leadership skills Applies advanced expertise and implements the operational strategic direction and guidance for respective clinical studies Demonstrates expert knowledge and a data driven approach to planning, executing, and problem solving Advanced communication skills via verbal, written and presentation abilities Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization Ability to influence and negotiate across a wide range of stakeholders Strong budget management experience An awareness of relevant industry trends Ability to build, lead and develop productive study teams and collaborations Applies advanced negotiation and interpersonal skills to vendor management Advanced technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC Extensive experience in global clinical trial operations with unique knowledge and skills to contribute to the development of protocols and key study documents Knowledge of ICH/GCP and regulatory guidelines/directives Advanced project management skills, cross-functional team leadership and organizational skills Line management experience In order to be considered qualified, a minimum of a Bachelor's degree is required and a minimum of 8 years relevant clinical trial experience. Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $0.00 - $0.00
We are seeking a highly skilled, experienced software Integration Engineer with experience in real-time data collection and analysis to join a diverse team of engineers, developers, analysts, and administrators to design, implement and support Data Acquisition and Analysis Systems. As a Senior Automation Systems Integration Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures. Integration of industrial automation systems, business applications and enterprise data platforms. Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automated control systems. Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines. Supporting small manufacturing, engineering, and validation projects. Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action. Authoring or updating system specifications, user and functional requirements specifications, generating and executing vital Factory Acceptance Tests (FAT) and (Site Acceptance Testing) SAT protocols. Reviewing cyber security vulnerabilities and risk pertaining to automation systems, software, and infrastructure Creation, modification, and maintenance of automation system documentation This role might be for you if you: Have experience with OT applications, including SCADAs, HMIs, Historians, etc. Experience working with advanced technologies such as OPC UA, MQTT, IIOT platforms, and data integration tools to create a centralized, real-time data architecture that supports Industry 4.0 initiatives. Are familiar with standing up large systems at the enterprise level Have core knowledge related to ISE S95, S88 principles and IT/Automation integration Have familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure Want to challenge the status-quo and champion an environment where continuous improvement is not just metrics - it's a mentality for everyone, every day, to do better Enjoy project-oriented work with a career goal of being regarded as an expert in keeping a biopharmaceutical process running smoothly Can balance changing priorities with increasing workload by making/communicating timely decisions To be considered for this position you ideally should have a bachelor's degree in Computer Science, Chemical, Mechanical, or Electrical Engineering and the following minimum years of relevant experience for each level: Senior Engineer: 5+ years Principal Engineer: 8+ years Level will be determined based on qualifications relevant to the role. #REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
We are seeking a highly skilled, experienced software Integration Engineer with experience in real-time data collection and analysis to join a diverse team of engineers, developers, analysts, and administrators to design, implement and support Data Acquisition and Analysis Systems. As a Senior Automation Systems Integration Engineer, a typical day might include the following: Designing, developing, and implementing software/hardware improvements to existing automated equipment and new equipment according to change control procedures. Integration of industrial automation systems, business applications and enterprise data platforms. Performing troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automated control systems. Developing and editing engineering design documents, technical evaluations, and test plans for cGMP process equipment while following GAMP 5 guidelines. Supporting small manufacturing, engineering, and validation projects. Providing support to process control and process monitoring equipment software design, commissioning, testing, and corrective action. Authoring or updating system specifications, user and functional requirements specifications, generating and executing vital Factory Acceptance Tests (FAT) and (Site Acceptance Testing) SAT protocols. Reviewing cyber security vulnerabilities and risk pertaining to automation systems, software, and infrastructure Creation, modification, and maintenance of automation system documentation This role might be for you if you: Have experience with OT applications, including SCADAs, HMIs, Historians, etc. Experience working with advanced technologies such as OPC UA, MQTT, IIOT platforms, and data integration tools to create a centralized, real-time data architecture that supports Industry 4.0 initiatives. Are familiar with standing up large systems at the enterprise level Have core knowledge related to ISE S95, S88 principles and IT/Automation integration Have familiarity with PLC communication, HMIs, computerized system design and maintenance of automation process control infrastructure Want to challenge the status-quo and champion an environment where continuous improvement is not just metrics - it's a mentality for everyone, every day, to do better Enjoy project-oriented work with a career goal of being regarded as an expert in keeping a biopharmaceutical process running smoothly Can balance changing priorities with increasing workload by making/communicating timely decisions To be considered for this position you ideally should have a bachelor's degree in Computer Science, Chemical, Mechanical, or Electrical Engineering and the following minimum years of relevant experience for each level: Senior Engineer: 5+ years Principal Engineer: 8+ years Level will be determined based on qualifications relevant to the role. #REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Within this role you will be responsible for specifies instrumentation for biopharmaceutical process & utilities systems and supports all aspects of the site calibration program. Evaluates new instrumentation for functional equivalence to existing instrumentation. Supports authoring and maintains configuration specifications & standards for cGMP manufacturing instrumentation. As a Senior/Prinicpal Instrumentation Engineer, a typical day might include, but is not limited to, the following: Understanding of common process & utilities instrumentation including but not limited to load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors Evaluating & specifiying cGMP instrumentation for new installations & for the upgrade of existing instrumentation with additional functionality, including instrument components & spare parts Being the technical SME for the site calibration program, providing technical guidance to calibrations operations team and supporting regulatory body inspections and audits. Evaluating new instrumentation for Functional Equivalence to existing instrumentation that has become obsolete Implementing corrective/preventative actions for existing instrumentation Working knowledge of process automation control systems. Conducting troubleshooting and root cause analysis for complex instrumentation and associated systems Creating and maintaining configuration specifications for cGMP manufacturing instrumentation Assisting in the design review of equipment, and approved supplier lists for instrumentation Reviewing and approval of wiring diagrams for instrumentation & associated control systems Preparing engineering evaluations and test plans for change control documentation. Writes and executes test plans to demonstrate instrument suitability Supervising engineering contractors, may be required Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by ensuring compliance with applicable regulatory authority requirements This role might be for you if: You possess logical troubleshooting and problem-solving skills You have good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a BEng/BS along with 5+ years experience for Senior Engineer level and 8+ years experience for Principal Engineer level. Experience with Biopharmaceutical Process & Utilities systems is preferred. REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Within this role you will be involved in start-up, normal operation, monitoring & shutdown, and maintenance of clean utilities, grey utilities and HVAC. This will include WFI, clean steam, bulk gases, bulk chemicals, process water generation, boilers, chillers, chemical dosing systems, cooling towers, air compressors, LPHW skids, waste water treatment, biowaste inactivation skids, HVAC system for cleanrooms and other mechanical equipment to provide utilities for buildings or industrial processes. The successful candidate will be required to work 24/7 shift which includes day & night shift. A typical day might include, but is not limited to, the following: Working on the daily operation and maintenance of a wide variety of HVAC, clean and grey utilities equipment in a modern GMP facility Diagnosing and resolving problems with utility systems and equipment Conducting routine inspections and preventative maintenance to ensure the reliable operation of systems and equipment Maintaining records of operation, maintenance, and safety activities, including test results, instrument readings, and details of equipment malfunctions and maintenance work Switching from automatic to manual controls and isolating equipment mechanically and electrically to allow for safe inspection and repair work Following safety procedures, including COHE, lockout/tagout, and handling hazardous materials when necessary Observing & interpreting readings on gauges, meters, and charts registering various aspects of utilities operation to ensure that equipment is operating properly Using the Building Automation Systems (BAS) to monitor and inspect equipment, computer terminals, switches, valves, gauges, alarms, safety devices, meters to detect leaks or malfunctions and to ensure that equipment is operating efficiently and safely Performing or arranging repairs, such as complete overhauls, replacement of defective valves, gaskets, bearings, or fabrication of new parts Operating facilities equipment and auxiliary equipment such as pumps, compressors, and air-conditioning equipment, to supply and maintain steam or heat for buildings and to meet industrial processes Testing boiler water quality or arrange for testing and take necessary corrective action, such as adding chemicals to prevent corrosion and harmful deposits Monitoring boiler water, chemical, and fuel levels, to make adjustments to maintain required levels Contacting equipment manufacturers or appropriate specialists when necessary to resolve equipment problems Controling and maintaining HVAC systems to support cleanroom environments This role might be for you if: You enjoy working collaboratively within a team You are self-sufficient and can manage responsibilities independently You possess logical troubleshooting and problem-solving skills You have a good understanding of utility systems and manufacturing equipment You are comfortable performing tasks with minimal supervision You want to expand your professional expertise in a regulated environment To be considered for this opportunity you should be qualified to National Craft Standard with a minimum of 2+ years' experience in a similar role. Will substitute additional relevant experience for educational requirement. #REGNIRLTO Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Within this role you will be working as part of the Manufacturing Team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors. As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to, the following: Working as part of the Manufacturing team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors Monitoring production processes Participating in equipment start-up, commissioning, and validation activities Assisting with troubleshooting in case of equipment failure Performing manufacturing level maintenance on equipment Adhering to safety and GMP (Good Manufacturing Practice) requirements at all times when carrying out tasks Performing equipment cleaning, preparation and execution as well as completing associated documentation Performing various tests and in-process sampling Reviewing, editing and revising completed batch records, logbooks, and SOPs in accordance with cGMP standards Maintaining housekeeping in designated area and adhering to the clean standards of the facility This role might be for you if: You possess excellent verbal and written communication skills You enjoy problem solving You demonstrate a can-do attitude You are proficient in Microsoft Word, Excel, PowerPoint, and Outlook You demonstrate an ability to work within a successful team You can adapt to a changing environment and have the ability to adhere to a schedule To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field. Relevant experience may be substituted in lieu of the educational requirement. Our site operates on a 24/7 basis, and we offer a number of different shift working patterns that could fit with your lifestyle What is on offer? You will be supported through a comprehensive onboarding programme which will include formal classroom learning along with on-the-job training all within an encouraging environment. Ensuring the health and well-being of our people is just as meaningful to us as the patients our life-transforming medicines serve. That's because we know caring for people around the globe should start with supporting our employees through our comprehensive compensation and benefits offering that includes: Competitive Salary Shift Premiums Annual Bonus Stock Schemes Employer Pension Contributions Education Assistance Generous Annual & Flexible Leave Programs Competitive Private Medical, Dental & Vision Plans Career & Personal Development Wellness Programs - Onsite Gyms & Fitness Classes Concierge Services - Onsite Beauty Therapist / Barber / Car Valet Community Volunteering Employee Interest Groups / Employee Teams & Clubs Employee & Family Events #REGNIELSM Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U. positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
