Within this role you will be responsible for providing QA oversight and support to activities in the Quality Control Laboratories. You will perform and lead oversight activities while maintaining and working within regulatory requirements, applicable policies and procedures as well as site expectations. A typical day might include, but is not limited to, the following: Performing and leading consultation or advice in alignment with QA policies Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls and CAPAs including active participation in investigation, evaluation, and problem resolution Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization Reviewing and approving Regeneron controlled documents Reviewing and approving investigations associated with product or processes Continually evaluates Regeneron processes and procedures with an eye toward continuous improvement May participate in internal, regulatory and customer audits This role may be for you if you: Have a strong quality perspective Demonstrate excellent attention to detail Are action-orientated and drive to meet timelines To be considered for this role, you should have a BSc/BA in scientific discipline or related field and a minimum of 2 years of relevant work experience in pharmaceutical or related cGMP environment/industry preferably with compliance management 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. 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.S.-based 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. #J-18808-Ljbffr
Overview Working within the Quality Assurance organization this position is responsible for ensuring IT systems, programs, and quality events are robust and compliant. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT‑related programs are in compliance with regulatory agency expectations and internal company policies and procedures. Typical day responsibilities As a Principal QA Specialist, a typical day might include the following: Supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits, and other verticals to ensure a robust, compliant state of programs Engaging with Corporate and IOPS IT to ensure IT processes and procedures meet Regeneron’s Quality System requirements Reviewing, editing, and approving SOPs, deviation notifications, deviation investigations, and corrective actions Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Collaborating, investigating, and troubleshooting to determine solutions or recommendations for changes and/or improvements Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives Supporting the development, review, and approval of Quality Assurance Agreements (QAA) along with the Approved Supplier List (ASL) process Contributing information reflecting best practices, industry trends, and recommendations for strategic plans to drive changes and improvements Communicating project and program status and metrics to Senior Management Who might be a good fit? Demonstrate strong interpersonal skills and can collaborate effectively Can balance changing priorities with a growing workload by communicating timely decisions Demonstrate knowledge of 21CFR11 and Annex 11 as well as MHRA, FDA, and WHO data integrity guidelines Have an understanding of the interdependencies of change management, deviation, and continuous improvement Can work in a dynamic organization where innovative solutions are required to ensure a high level of quality is achieved with aggressive timelines To be considered for this position you should have a BSc/BA/BEng in IT/Automation/Analytics or related field and 5‑7 years of experience or an equivalent combination of education and experience. Recent experience in a data integrity role is preferred; however, it is not required. Benefits We have an inclusive culture that provides comprehensive benefits. 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 other countries’ specific benefits, please speak to your recruiter. Equal Opportunity Statement 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. #J-18808-Ljbffr
Regeneron Pharmaceuticals, Inc is seeking an ITOT Infrastructure Support Technician in Munster, Ireland. This role involves providing IT support to Manufacturing, ensuring smooth operation of IT equipment and applications, and troubleshooting issues. Candidates need an Associate's degree in IT and relevant experience, along with technical competence in IT hardware and applications. The position requires strong communication skills and adherence to clean room standards. Benefits include comprehensive programs and an inclusive culture. #J-18808-Ljbffr
Regeneron Pharmaceuticals, Inc in Munster, Ireland is seeking a dedicated team leader for laboratory quality control testing. The successful candidate will oversee a QC team, ensuring compliance with cGMP regulations while managing product testing and personnel functions. Candidates should have a minimum of 7+ years of experience in a managerial capacity. In addition, strong coordination and analytical skills are essential for success in this role, which includes interacting with regulatory agencies to maintain compliance. #J-18808-Ljbffr
Responsibilities Within this role you will oversee a team involved in laboratory quality control testing, and has technical responsibility for all aspects of QC testing. Typical day might include, but is not limited to, the following: Coordinating with members of Manufacturing, Stability, and Business Ops to provide analytical support Managing QC Analysts, distributes work load, and monitors progress Managing product testing to ensure efficient and compliant operations Ensuring QC Analysts receive proper training Attending meetings to keep informed of manufacturing priorities Ensuring that safety standards are maintained Ensuring compliance with applicable cGMP regulations and SOPs Investigating a typical and OOS test results as necessary Managing transfers internally from R&D to the QC laboratory or from PAS to the QC Laboratory Managing transfers externally from QC laboratory to contract labs, includes audits if needed Managing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness Tracking and monitoring the timeline of analytical validation projects Monitoring the team performance for Compliance events, track, assist and organize continuous improvement events Interacting with Regulatory Agencies as needed to ensure cGMP compliance Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations Qualifications This role may be for you if you: Contribute to special projects as assigned Demonstrate strong coordination during major analytical investigations Review and approve test reports for accuracy and compliance Education and Experience Manager : Minimum 7+ years of experience Senior Manager: Minimum 8+ years of experience 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. #J-18808-Ljbffr
Regeneron Pharmaceuticals, Inc is seeking an Associate Process Scientist in Munster, Ireland. This 12-month temporary role involves delivering process solutions, conducting root-cause analysis, and preparing reports. Required qualifications include a BS/BA in Life sciences or Engineering, strong teamwork skills, and effective communication abilities. The position offers a comprehensive benefits package, including health programs and paid time off. #J-18808-Ljbffr
Role Overview Within this role, the Associate Process Scientist sits within the Technical Services department, which supports a broad range of scientific, technical, engineering, and mathematical activities spanning both laboratory operations and the manufacturing floor. Process Sciences support the following areas: Upstream Sciences, Downstream Sciences, Analytical Technologies, IPC lifecycle, Data Analytics, Manufacturing Support, Process Validation and Process Solutions. This is a 12‑month temporary position. Responsibilities Supporting delivery of process solutions to IOPS and contributing to best‑in‑class laboratory and process validation report packages Assisting in root‑cause analysis of process‑related deviations using scientific data‑driven rationale. Participating in cross‑functional teams to understand process issues in technical and laboratory investigations Contributing to knowledge‑based reports summarising conclusions of studies, investigations, and process improvements Presenting findings at group meetings Producing and maintaining accurate records in accordance with site procedures and guidelines Qualifications Ability to work well in a team environment Strong written and oral communication skills BS/BA in Life sciences, Engineering or related field (alternative disciplines may be considered if the candidate demonstrates relevant experience) Prior cGMP experience is desirable Benefits We offer a comprehensive benefits package that may include health and wellness programs, 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. For more information visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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. #J-18808-Ljbffr
Regeneron Pharmaceuticals, Inc in Munster, Ireland is seeking a Senior Electrical Engineer responsible for designing, specifying, and commissioning electrical systems. The role involves managing projects related to electrical infrastructure, maintaining compliance with health and safety regulations, and ensuring operational availability of electrical networks. Candidates must have a Bachelor’s degree in Electrical Engineering and 5+ years of experience in a regulated industry. A comprehensive benefits package is offered. #J-18808-Ljbffr
We are seeking a Senior Electrical Engineer who will design, specify and commission new and renovated electrical systems. The candidate will provide engineering support and problem solving for new capital projects, existing equipment and manufacturing processes and work in conjunction with the electrical maintenance team to ensure operational availability of electrical distribution networks. Typical Day Design and maintain LV (Lighting, General Services, UPS, Protection Settings including Arc Flash) and ELV (Fire Alarm, Data points, Building Automation) systems Manage small projects related to electrical systems infrastructure Assist in design review, site acceptance and installation of electrical equipment Prepare and maintain electrical drawings and related documentation Design and specify cGMP E&I equipment and process controls Manage electrical systems residing on the business IT network Support validation department by preparing design documents and assisting in protocol execution Assist in investigations of equipment and control system anomalies, including power quality events Prepare engineering evaluations for and execute modification change control documentation Supervise electrical contractors and confirm works meet required standard Prepare risk assessments, method statements and all aspects relating to Health and Safety on site Maintain a clean and safe working environment by enforcing procedures, policies and regulations Safely operate and manage HV network Maintain company reputation by enforcing compliance with all relevant laws, policies, standards and regulations Qualifications Excellent technical and analytical skills Skilled at problem solving and continuous improvement Strong communication and collaboration skills Adaptable and able to work in a fast‑paced, regulated environment Bachelor’s degree in Electrical Engineering or a relevant discipline 5+ years’ experience working in a regulated industry The level will be determined based on qualifications and experience relevant to the role. Benefits Regeneron offers a comprehensive benefits package that may include health and wellness programs (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. Regeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, gender, sexual orientation or identity, disability, and other protected characteristics 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 such accommodation would impose undue hardship on the operation of the Company’s business. #J-18808-Ljbffr
Within this role you will facilitate and coordinate inventory, documentation and perform record‑related activities for manufacturing. Maintain and coordinate inventory, scheduling, sampling, and documentation requirements for manufacturing. Typical Day Responsibilities Coordinating, reviewing, and cataloguing various types of manufacturing documentation Preparing routine progress reports and tracking on various KPIs Managing lifecycle management of documentation Maintaining inventory systems through investigations, weekly reviews, reconciliations, and other related activities to ensure accuracy Serving as a liaison between manufacturing and other functional areas as needed Performing analysis of GMP and GxP data Coordinating appropriate material needs using varying systems and forms to ensure production continuity Ensuring systematic bill of materials are created and maintained for production needs Evaluating, initiating, and monitoring deviations and other compliance events Creating and reviewing sampling intake for all manufacturing unit operations and protocols per the appropriate documentation prior to operators going on the floor Who might be a good fit? You have the ability to decipher and navigate a variety of different systems, data, calculations, and documentation You have experience within a GMP environment and have good GDP knowledge You possess excellent verbal and written communication skills You enjoy problem solving You demonstrate a can‑do attitude You are proficient in Microsoft Word, Excel, PowerPoint, and Outlook To be considered for this opportunity you should have a B.S./B.A. Degree with 0‑2+ years of related experience or an equivalent combination of education and experience. Experience in a cGMP environment, quality assurance, project management, or inventory management is desired. Benefits 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 U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. 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 Traveller 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.S.-based 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. #J-18808-Ljbffr
