The Staff IT Compliance Analyst plays a critical role in ensuring that the Manufacturing IT group operates in full compliance with regulatory requirements, industry standards, and Regeneron's internal quality procedures. This role also oversees the preparation and management of internal and external audits to maintain a state of inspection readiness. As a Staff IT Compliance Analyst, a typical day might include the following: Providing expert guidance and analysis to the Manufacturing IT team on regulatory compliance, quality assurance, and inspection readiness, while managing internal programs to ensure audit preparedness. Evaluating, developing, and refining Manufacturing IT policies, standard operating procedures (SOPs), and practices to align with regulatory requirements, corporate quality standards, and industry best practices. Representing and supporting Manufacturing IT subject matter experts (SMEs) during internal and external audits, while leading the development and execution of responses to audit findings. Establishing, maintaining, and improving metrics to monitor IT compliance, inspection readiness, and audit outcomes, and effectively communicating these findings to stakeholders. Collaborating with global sites to ensure deployed systems comply with business needs, regulatory expectations, and data integrity requirements, while promoting a culture of quality and continuous improvement. Monitoring industry trends in audit observations and regulatory changes, identifying potential compliance gaps, and implementing timely corrective or preventive actions. Supporting IT quality processes, including managing IT deviations, change controls, and the creation or revision of IT quality documents, while demonstrating flexibility and cross-functional expertise. This role may be for you if you have: A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes. Proven ability to apply quality assurance principles to IT compliance activities, ensuring systems and processes meet both regulatory and corporate quality standards. Strong analytical and problem-solving skills, with a proactive approach to identifying and resolving compliance risks. Excellent communication and collaboration skills to work effectively across global teams and interact with regulatory inspectors or auditors. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field required along with Principal IT Compliance Analyst: 8 years of relevant experience. Staff IT Compliance Analyst: 10 years of relevant experience. May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Quality Assurance (QA) experience strongly desired. Experience in the pharmaceutical or biotechnology industry 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. TPBN1_IJ
Within this role, you will report to the Payroll Manager. The Manager will be responsible for supporting the Payroll Manager and the wider team with all day-to-day activities involved in delivering the end-to-end payroll process. This is a 18-month temporary contract. A typical day might include, but is not limited to, the following: Conducting payroll audits and reviews prior to Associate Director Approval Working with accounting to ensure all payroll data required for month end is provided in a timely and accurate manner Preparing and/or reviews and inputs all administrative payroll data changes to records for processing of our bi- weekly and monthly payroll Working with other departments such as Comp & Bens and HRPB's to ensure payroll data is correct and processed accordingly Reconciling each payroll, reviews all entries and forwards for approval Ensuring all tax information, reconciliations and payments Managing the internal inbox with responsibility for responding to employees' queries Assisting with audit queries related to payroll Performing other duties or projects as assigned by management This role may be for you: You thrive in a fast-paced, deadline-driven environment and can juggle multiple priorities You communicate clearly and effectively with internal teams and external partners You are comfortable working hands-on while providing strategic oversight You have strong analytical skills and a keen eye for detail To be considered this opportunity you should a bachelor's degree in accounting, finance, or business as well as 6/7 years of experience. Advanced Excel skills (including pivot tables, formulas, and lookups), experience with Workday, Oracle or Core is strongly preferred have a payroll experience, including having worked as a payroll manager with direct people management responsibilities. Education and Experience: Associate Manager: Minimun 6 years of experience Manager: Minimun 7 years of 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. TLNT1_IJ
In this role you will be responsible for automation and controls systems project management towards specification, design, start-up, and commissioning in a cGMP environment. As an Associate Automation Engineer, a typical day might include the following: Managing projects related to design, commissioning, and performance improvement of automated equipment Providing design/approval of hardware, software, and controls for automated equipment Providing technical and automation operational support to Manufacturing and Facilities Implementing software/hardware changes and upgrades, understands impact of actions to Manufacturing and Facilities Implementing modification/change control procedures and protocols Supporting the Validation Department with initial design review, software testing, protocol execution and review Programming PLC and HMI application for automated process equipment, capable of troubleshooting and demonstrates knowledge of instrumentation and controls This role may be for you if you: Are a self-starter with high initiative and possess a data-driven approach to problem-solving Have strong interpersonal skills Have demonstrated adaptability and flexibility to working in different environments and teams In order to be considered for this position, you must hold a BS/BEng or higher in Science, Engineering, Instrumentation or Software Programming. May substitute relevant experience for education. 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. TLNT1_IJ
The Director Program Operations Leader (POL) is responsible for leadership of and setting and implementation of the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. Director Program Operations Leader - Oncology (For US Locations, this position is on-site 4 days per week and 1 day from home. For Uxbridge and Dublin, colleagues must be on-site 3 days per week and 2 days from home. A fully remote role is NOT possible for this position.) In a typical day, you will: Be responsible for the overall success of the clinical study team(s) within a program(s) Maintain an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to stakeholders as requested Provide operational insight into feasibility, timeline and cost estimates during clinical program/study development Oversee clinical study timelines within a clinical program(s) Provide input and operational insight into Clinical Study Concepts (CSC) Be responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol Review plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of best practices within CTM Oversee clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate Ensure timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s). Drive decision making and integrates all operational considerations for studies within a clinical program(s) to ensure goals are attainable prior to implementation Act as point of contact for clinical program and study level escalation Review key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress Provide proactive creation and implementation of risk mitigation strategies Provide innovative and flexible operational solutions and options to the cross functional and development teams; assists in preparing scenarios for creative solutions to operational challenges Drives the strategy and oversight for vendor selection and management within a clinical program(s) Manages the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables and relationship with key CRO (functional and project) and vendor counterparts May require up to 25% travel To be considered, you must possess a Bachelor's degree and a minimum of 12 years of related in-house sponsor-side pharmaceutical experience, with 8 years in clinical operations. 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) $205,000.00 - $341,600.00 TPBN1_IJ
We are seeking an Associate Project Engineer who will 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 you: Are a self-starter with high initiative and possess a data-driven approach to problem-solving Have demonstrated strong interpersonal skills Are able to prioritize, re-prioritize as needed and adapt to change Have strong analytical and organizational skills Have 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. TPBN1_IJ
The Manager, Trade & Distribution Operations is a key member of the team, responsible for end-to-end oversight of distribution and order fulfillment across Spain/France, Switzerland, and EU Rare Disease channels. Collaborating with internal teams, external vendors, customers, and logistics partners, you will be driving operational performance, vendor collaboration, regulatory/GDP compliance, budget stewardship, and continuous improvement to ensure reliable, efficient delivery. A Typical Day Communicate proactively with internal and external collaborators to resolve distribution customer concerns and issues while maintaining high standards of order fulfillment. Serve as the primary point of contact for vendors and partners; maintain collaboration and ensure adherence to contractual obligations and SLAs. Be responsible for day-to-day distribution operations to ensure timely delivery, adherence to schedules, and operational efficiency. Conduct regular vendor performance reviews and prepare quarterly reports for internal leadership and external collaborator presentations. Provide oversight of 3PL activities with regulatory and contractual requirements, including GDP standards. Handle and supervise distribution budgets, balancing cost efficiency with quality service delivery; track variances and drive corrective actions. Track and report distribution metrics such as delivery timelines, inventory levels, and vendor performance; surface insights to guide decisions. Rectify data anomalies using internal dashboards and systems; ensure accurate reporting, detailed data integration, and data integrity. Support contract development, amendments, and compliance in collaboration with Legal and cross-functional teams. Resolve claims efficiently; establish standard operating procedures and conduct proactive reviews to optimize workflows and reduce recurrence. Develop and maintain policies and procedures that strengthen distribution strategies and vendor relationships. Ensure compliance with trade regulations, GDP standards, and other relevant distribution requirements across the broader EU operations. Collaborate with cross-functional teams (e.g., Quality, Finance, Customer Service, Supply Chain, Commercial) to implement process improvements aligned to organizational goals. Produce reports and briefing materials for senior management on distribution performance, vendor adherence, and risk/mitigation status. Identify and mitigate risks and dependencies early; recommend pragmatic solutions and secure cross-functional alignment on course corrections. This Role Might Be for You If You Have Hands-on experience leading distribution operations across Europe, especially ES/FR and Switzerland, with exposure to rare disease or specialty distribution. Vendor and 3PL management expertise, including contract oversight, SLA governance and performance reviews. Strong understanding of GDP, trade regulations, and compliance expectations for pharmaceutical/healthcare distribution in the EU and Switzerland. Data fluency and analytical skills, including dashboarding and KPI reporting Budget management experience with a focus on cost optimization and service quality. Excellent communication and collaborator, adept at handling partner concerns and driving outcomes in a matrixed environment. Process improvement demeanor with experience in standardizing procedures and implementing efficiencies High attention to detail, organization, and follow-through; ability to balance multiple priorities and deadlines. Willingness to travel to vendor sites, 3PLs, and regional partners as needed. To Be Considered Bachelor's degree in supply chain or a related field. 6+ years of experience in distribution/trade operations, logistics, or vendor management, with a European focus 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. TPBN1_IJ
The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness. For US locations (Armonk, NY or Warren, NJ), this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position. A day in the life may look like: Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process. Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas. Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team. Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending. Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system. Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP. This may be the right role for you if you have experience: Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience. Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP). Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines. Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process. Supporting the collection and reporting of data (e.g., metrics). Contributing to and supporting process improvement initiatives and workgroups, as assigned. Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ. 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 TPBN1_IJ
The Principal Technical Analyst - Manufacturing Systems will serve as a technical expert responsible for implementing and integrating manufacturing technologies across our biopharmaceutical facilities. You will execute hands-on technical builds and integrations spanning Nymi biometric systems, IBM Maximo EAMS (Enterprise Asset Management System), and related manufacturing technologies, ensuring compliant deployment that supports operational excellence and predictive maintenance capabilities. As a Principal Technical Analyst - Manufacturing Systems , a typical day might include the following: Execute technical builds and integrations for manufacturing systems including Nymi biometric authentication, IBM Maximo EAMS, MES platforms, and associated technologies across designated facilities or project portfolios. Implement integration solutions connecting Maximo with predictive maintenance systems, MES workflows, and biometric access controls, following established architectural frameworks. Configure IBM Maximo EAMS modules including work management, asset management, and predictive maintenance capabilities for future release implementations. Build and test Nymi biometric integration points with manufacturing systems to enable secure, compliant user authentication workflows. Execute validation protocols (SDLC Framework aligned to CSA) for manufacturing technology implementations in FDA-regulated environments, ensuring documentation meets regulatory standards. Implement change control procedures for system modifications, maintaining compliance throughout the development lifecycle. Configure master data elements within assigned systems following established data architecture standards. Support transformation of paper-based processes into digital workflows while maintaining regulatory compliance requirements. Diagnose integration problems between Maximo, biometric systems, MES platforms, and automation equipment (Ignition, DeltaV, Rockwell). Partner with senior technical leads, automation engineers, and site stakeholders to understand requirements and deliver technical solutions aligned with business objectives. This role may be for you if you have: Practical experience dealing with project management, particularly dealing with the implementation of new technology and ways of doing things. Ability to understand and engage broader business strategy, work with key department leaders and stakeholders and align activities and initiatives. A demonstrated ability in creation of requirements, design documents and test scripts. Must be competent to work at the technical level of all phases of system design and implementation. Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills. Ability to anticipate client needs and propose alternative business solutions Knowledge of GMP, 21 CFR Part 11 and Annex 11. In order to be considered for this position, you must hold a BS/BA degree in Information Technology or related field required along with Principal: 8+ years of progressive industry/relevant experience. Staff: 10+ years of progressive industry/relevant experience. Level is determined based on qualifications relevant to the role. 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. TPBN1_IJ
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. TPBN1_IJ
Within this role The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands-on solving issues during technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of off-site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations. As a Drug Product MSAT Engineer, a typical day might include the following: Providing drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution Acting as the technical lead, with the support of cross-functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities Assisting with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations Trending process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations Authoring policies, technical reports/protocols, change controls, etc. in support of cGMP activities Supporting development of sampling plans for GMP batches related to lot release, stability and characterization Assisting in equipment selection, qualification and start up activities. Working with manufacturing to ensure robust procedures are utilized for operation of equipment Partnering with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery Maintaining required training status on Regeneron specific work instructions and SOPs To be considered for this role you should have a BS/BA in engineering and 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience. Travel to contract manufacturers or business partners, as required, up to 25-50%. Education and Experience: Associate Engineer: Minimum 0-2 years of experience Engineer: Minimum 2 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. TPBN1_IJ
