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.
At Regeneron, we are dedicated to transforming lives through innovative medicines and empowering healthcare. We are looking for an outstanding Associate Director, Good Pharmacovigilance Practice (GVP) Audits to join our Global Development Quality Assurance (GDQA) team. This pivotal role offers the opportunity to lead and supervise GVP audits across all aspects of the Regeneron Pharmacovigilance System. As a key member of GDQA, you will play a vital role in ensuring compliance, driving innovation, and mentoring top talent in the field. A Typical Day in This Role: Lead risk-based quality auditing activities, ensuring alignment with international regulations and internal requirements. Oversee the execution of GVP audits, including scheduling, preparing, conducting, reporting, and follow-up. Develop and implement new audit standards and methods to stay ahead of technological advancements in global development. Provide guidance and mentorship to audit teams, encouraging professional growth and excellence. Manage GDQA resources effectively to meet annual audit schedules and priorities. Conduct training sessions for GDQA personnel and relevant departments, improving organizational knowledge and skills. This Role May Be For You If: You have a deep understanding of EU and FDA Pharmacovigilance regulations, ICH guidance documents, and other relevant compliance standards. You thrive in dynamic environments and excel at managing multiple high-priority tasks with urgency and precision. You are a strong leader with experience mentoring teams and interfacing with senior/executive leaders. You possess exceptional problem-solving skills and can navigate complex situations with critical thinking and strategic insight. To Be Considered: Candidates should possess a bachelor's degree and have at least 11 years of relevant proven experience, including 9+ years of direct GVP auditing and/or industry experience. Strong communication skills and a proven track record in audit and project management are essential. Experience with EU or other regulatory inspections is desirable. Preferred candidates will show talent in stakeholder management, teamwork, critical thinking, and negotiation of complex situations. 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. Benefits: Work From Home
The Principal IT Lab Integration Developer is responsible for designing, developing, validating, and supporting integrations between laboratory systems, analytical instruments, enterprise platforms (LIMS), and data platforms within a regulated pharmaceutical environment. This role combines application development, system integration, data management, and regulatory compliance within a GMP-regulated laboratory environment. As a Principal IT Lab Integration Developer, a typical day might include the following: Support the design and implementation of the QC Lab Orchestration Layer, enabling workflow coordination across all Laboratory instruments and middleware. Define integration patterns (APIs, event-driven, message queues, file-based where needed). Ensure scalability, resilience, and performance of lab integrations. Translate QC business processes into orchestrated digital workflows. Design and develop integrations between instruments and the Orchestration Layer. Build and support API-based, file-based, and message-based integrations (REST, SOAP, SFTP, JSON, XML). Provide level 2/3 support for QC Lab Systems. Partner with QC Analysts, QA, IT infrastructure and external vendors. Develop instrument data capture and automation workflows. Configure and support middleware and integration platforms. Ensure all integrations comply with GxP, 21 CFR Part 11, and data integrity (ALCOA+) requirements. Participate in Computer System Validation (CSV/CSA) activities (IQ/OQ/PQ documentation). Perform impact assessments and change control documentation. Monitor and troubleshoot integration issues in production environments. Collaborate with QC, R&D, Manufacturing, and QA teams. Support audits and regulatory inspections. This role may be for you if you have: Skill in connecting various lab instruments (e.g., liquid handlers, analyzers) to central platforms like LIMS or ELNs to automate data capture and reduce manual transcription. Knowledge of RESTful APIs, web services, and middleware tools used to bridge communication between the orchestration engine and disparate lab hardware. Proficiency in languages such as Python or VBA for customizing automated workflows and data parsing. Ability to understand data formats across different systems, ensure consistent values/naming conventions, and providing the correct data to the authorized locations In order to be considered for this position, you must hold a BS/BA in Information Technology, Math or related field and Senior: 5 years of relevant experience or equivalent combination of education and experience. Principal: 8 years of relevant experience or equivalent combination of education and experience. 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- CMC Regulatory Submission Compliance is responsible for aligning the regulatory landscape with country-specific requirements and supporting clinical regulatory submission activities, supply planning, and QP certification. This role leads processes and cross-functional coordination, ensuring high-quality documentation and timely approvals for clinical and commercial activities. A Typical Day: Provide support for the management of the regulatory submission form process, reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets. Lead and coordinate the pre-submission review process to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations. Participate in cross-functional meetings to identify CMC regulatory issues related to submission documentation; ensure clear communication between IOPS and global development on submission-related risks. Develop and improve procedures and systems for review and feedback on the CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency. Lead meetings and presentations on complex regulatory issues; contribute to and build regulatory justifications to support filings. Provide CMC regulatory submission oversight of CRO activities, ensuring deliverables meet compliance standards and timelines. Keep management and collaborators advised of assessments, overall strategy, and project status through structured reporting and updates. Implement comprehensive training, tools, and reporting metrics for senior management to strengthen submission compliance and operational readiness. Act as a submission compliance liaison with Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of investigational product. Support activities by ensuring documentation completeness and compliance. Mentor, coach, and, where applicable, manage direct reports to develop regulatory capabilities and consistent practices. This Role Might Be for You If You Have: A Bachelor's degree in Chemistry, Biology, or a related field; advanced qualifications or program management experience are a plus. 8+ years of experience in the biotech or pharmaceutical industry, including a minimum of 2 years of relevant CMC experience. 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. Salary Range (annually) $134,400.00 - $219,200.00
We are currently looking to fill an Associate Director Global Procurement, R&D position within our team. In this role you will be responsible for all Procurement activities in support of the global clinical CRO category. As an Associate Director will manage categories with high degree of complexity, as well as executing challenging supplier negotiations and delivering high service level to the business. In this role, you must demonstrate the capability to proactively manage a supply base and maximize value, minimize risk, and ensure quality & cost effectiveness by working collaboratively with business unit. In this role, a typical day may include the following: Help define and implement the global CRO Category strategy to serve global and regional business needs. Work closely with stakeholders to lead discussions related to the CRO Category and aligns category priorities with Procurement management and stakeholders. Manage negotiations, supplier management activities, and stakeholder engagement activities for the CRO Category as assigned. Work with leadership to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. Manage category activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. Demonstrate knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the Global Procurement organization and leverages this knowledge to drive improvements within Regeneron, aligned with corporate priorities. Negotiates contract terms and conditions in consultation with Law department aligned with Regeneron's priorities and business requirements. Can directly or through a matrix structure, manage team of professional level employees responsible for performing category management tasks (if applicable.) Can provide coaching and guidance on job performance and career development to direct reports (if applicable) and provides leadership examples for the organization. Uses data to drive decision-making for successful category projects. This role may be for you if you: Can negotiate contract terms and conditions in consultation with Law department aligned with Regeneron's priorities and business requirements. Have working knowledge with sourcing contracting tools, ERP's, and eRFx systems preferred. (Oracle, Zycus, Ariba, Other) Have the ability to leverage standard business applications for communicating, presenting and analyzing (Word, Excel, PowerPoint) Have used external data sources, market information, and supplier engagement to constantly improve Regeneron's knowledge of supply market dynamics. Are able to demonstrate success managing cross-functional teams to drive results in Clinical Trial categories or related categories through effective sourcing, negotiations, contracting, and supplier relationship management. Can demonstrates knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the Global Procurement organization and leverages this knowledge to drive improvements within Regeneron, aligned with corporate priorities. To be considered for this role you must hold a Bachelor's degree in a relevant field of study plus progressive experience in procurement, preferably including experience in Pharma/BioPharma. Associate Director level: 10+ years of experience in relevant experience, functions or industries. The ideal candidate will have in-depth knowledge of managing global category processes, and suppliers across a breadth of categories 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. Salary Range (annually) $157,200.00 - $256,600.00
At Regeneron, we believe that when the right idea finds the right team, powerful change is possible. We're looking for a Senior Manager, Global Site Management and monitoring, to join our team and play a pivotal role in coordinating and improving the delivery of clinical trial operations. In this role, you'll contribute to the planning, execution, and oversight of our clinical trial portfolio, ensuring collaboration among internal teams, external vendors, and investigator sites. With opportunities to drive innovation and process improvement, this position offers meaningful impact in advancing clinical trial strategies and methodologies. A Typical Day: Develop and be responsible for study-specific risk-based monitoring strategies to ensure compliance and efficiency, while managing vendor relationships, including onboarding, performance evaluations and resource alignment. Collaborate with Clinical Trial Management teams to design monitoring strategies aligned with RBQM methodologies, including budget planning and approval. Provide input to monitoring plans, ensuring alignment with critical data specifications and SDR/SDV approaches. Oversee and evaluate performance metrics and risk indicators, providing intervention as needed. Act as an SME for monitoring/site management topics, offering guidance to internal and external stakeholders. Support inspection readiness activities and participate in regulatory GCP inspections and audits. This Role May Be For You If: You have extensive experience with risk-based quality operating models and clinical trial operations. You excel in collaborative environments while maintaining the ability to work independently. You are skilled in establishing relationships with stakeholders and translating strategies into actionable frameworks. You are familiar with medical terminology and industry regulations, including ICH/GCP standards. To Be Considered: Applicants must have a Bachelor's Degree and at least 8 years of proven experience in clinical trial operations, monitoring, and site management. A proven understanding of ICH/GCP standards and familiarity with medical terminology are crucial. Preferred qualifications include experience in risk-based monitoring methodologies and expertise in collaborating with CROs and FSPs. This position involves travelling up to 10% of the time to support site management activities. 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 an Associate Project Engineer who would design, specify and commission new and renovated biopharmaceutical process equipment. This role will provide engineering support and assist with problem solving for existing equipment and manufacturing processes. As an Associate Project Engineer, a typical day might include the following: Designing and specifying cGMP process equipment, piping, and/or controls Managing small projects related to process equipment and manufacturing Assisting in the design review, site acceptance and installation of equipment Preparing process and instrument drawings and other related drawings Developing Process Flow Diagrams for manufacturing processes Supporting validation department by preparation of design documents and assists in protocol execution Assisting in investigations of process equipment and control system anomalies Implementing corrective/preventative actions for existing equipment and manufacturing processes Preparing engineering evaluations for and executing modification change control documentation May supervise mechanical, electrical, and automation contractors This role might be for you if: Self-starter with high initiative and data-driven approach to problem-solving Demonstrated strong interpersonal skills You are able to prioritize, re-prioritize as needed and adapt to change You have strong analytical and organizational skills Demonstrated adaptability and flexibility to working in different environments, teams etc. To be considered for this position you should have a BEng or higher in Chemical, Process or Mechanical Engineering. 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 Sr/Automation Manager who will be responsible for leading the design, implementation, validation, and lifecycle management of automation systems supporting bioprocessing, laboratory, and manufacturing operations. This role will ensure operational efficiency, regulatory compliance, data integrity, and continuous improvement across all automated platforms within a regulated biotech environment. As a Sr/Manager Automation, a typical day might include the following: Managing a team of FTE's and contractors in order to meet end user requirements Working with System Owners to prioritize change control requests, releases and enhancements Providing oversight for the design, implementation, and support of automation equipment Maintaining adherence to ALCOA+ data integrity principles Developing, implementing and driving operational rigor and discipline using metrics and other operational controls as needed Presenting status of System Operations and Project Status to executive stakeholders and ensuring alignment of resources to key priorities Developing continuous improvement ideas that improve team performance and efficiencies Ensuring projects are completed on time and within budget Performing monthly staff performance reviews and developing annual performance evaluation of staff Developing and executing the site automation strategy aligned with business and operational goals Capable of leading cross-functional automation projects from concept through commissioning and validation Overseeing automation budgets, project timelines, and external vendor partnerships Ensuring compliance with 21 CFR Part 11 and GxP requirements Supporting internal and external regulatory audits Ensuring automation systems comply with regulatory agencies, IOPS policies and procedures requirements Supporting digital transformation and Industry 4.0 initiatives Coordinating preventative and corrective maintenance programs This role might be for you if you: You are a self-starter with high initiative and possess a data-driven approach to problem-solving You demonstrate strong interpersonal skills and have previous experience managing a team You are experienced operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement 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 Can balance changing priorities with increasing workload by making/communicating timely decisions To be considered for this position you should have a BSc/BA in IT/Automation/Analytics or related field and the following minimum years of relevant industry experience for each level: Manager: 7+ years Senior Manager: 8+ years #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 Senior Project Engineer who will be responsible for designing, specifying and commissioning new and renovated biopharmaceutical process equipment. This position will provide engineering support and problem solving support for existing equipment and manufacturing processes. As a Sr Project Engineer, a typical day might include the following: Designing and specifying cGMP process equipment, piping, and controls Managing small-to-mid-sized projects related to process equipment and manufacturing Assisting in the design review, site acceptance, and installation of equipment Preparing piping and instrumentation diagrams (P&IDs) and other related drawings Developing Process Flow Diagrams (PFDs) for manufacturing processes Supporting the QA Validation department by preparing design documents and assisting in protocol execution Reviewing and approving lifecycle documentation, cleaning validation protocols, and summary reports Assisting with investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents Assisting management with tracking of department throughput and efficiency Representing the engineering department at cross-functional meetings Supervising direct reports as needed Implementing corrective/preventative actions for existing equipment and manufacturing processes Preparing engineering evaluations and test plans, and executing change control documentation Supervising mechanical, electrical, and automation contractors as needed Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by ensuring compliance with all relevant laws, policies, and regulations This role may be for you if: You have excellent technical and analytical skills. You are skilled at problem-solving and continuous improvement. You possess strong communication and collaboration skills. You are adaptable and can work in a fast-paced, regulated environment To be considered for this opportunity you should have a BS/BEng or higher in chemical/process/mechanical engineering with 5+ years of related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education. #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 support lifecycle management within the QC Technical Resources group. You will participate (Perform, Review, Co-ordinate) in assay development, characterization, optimization, transfer, validation and investigation for QC group. You may provide technical support, guidance and supervision for release, stability, and in-process testing and assay development as a subject matter expert (SME). Please note this is a 12-month contract position. As a Temp QC Technical Resources Specialist, a typical day might include, but is not limited to, the following: Collaborating with Analytical Sciences (AS) to integrate methods into QC Commercial evaluating and selecting suitable methods prior to process validation Monitoring and analyze daily method performance in the QC lab, coordinating with subject matter experts for problem resolution as needed Liaising with Regulatory Sciences and External Manufacturing to manage timelines for method validation and transfers, communicating updates to management Monitoring method updates, performance, and quality metrics, ensuring consistent harmonization and performance evaluations across multiple sites Coordinating post-transfer investigations and multi-site trending, escalating issues to management when necessary Driving process improvements and support investigational analysis, performing and coordinating assay qualifications and transfers Developing and drafting new test procedures and assays, authoring technical documents like Analytical Development and Validation Reports Participating in training programs for QC personnel, ensuring all activities align with project timelines and deliverables This role may be for you if you have: The ability to work independently or as part of a team Strong skills in planning, critical thinking and problem-solving, ability to follow directions and perform well-defined tasks Excellent written and oral communication skills The ability to develop strategy and create metrics to measure effectiveness of strategy To be considered for this opportunity you should have a BS/BA in a life sciences field and 2 years of experience or equivalent combination of education and experience. Scientist level minimum 2 years of experience Sr Scientist level minimum 5+ years of experience #REGNIEEC 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.
