Manufacturing Process Compliance Lead

Regeneron Pharmaceuticals, Inc.; Limerick; On-site; EUR 37,000 - 88,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join our Manufacturing team in Limerick. The role focuses on troubleshooting manufacturing processes, developing personnel, and driving CAPA, with emphasis on cGMP compliance and documentation.

You will collaborate across functions to monitor trends, lead technology transfer, and ensure timely completion of validation activities, while maintaining high safety and quality standards.

Qualifications

• BS/BA/BEng in Life Sciences or related field and 2 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• Sr Specialist: BS/BA/BEng in Life Sciences or related field and 5 years experience

Responsibilities

• Providing technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor
• Coaching and developing manufacturing personnel to strengthen technical knowledge, process understanding, and operational capability
• Supporting process improvements, CAPA implementation, and work system enhancements to drive performance and compliance
• Leading technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams
• Monitoring, analyzing, and presenting process trends, technical metrics, and operational data to support informed decision-making
• Conducting investigations into process variances and ensuring adherence to cGMP, regulatory requirements, site procedures, and safety standards
• Overseeing validation activities, equipment ownership responsibilities, and the scheduling of non-routine manufacturing operations
• Authoring, reviewing, and approving controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives

Skills

Troubleshooting

Process troubleshooting

Data analysis

Cross-functional collaboration

Education

BS/BA/BEng in Life Sciences or related field

2 years relevant cGMP manufacturing/engineering/scientific experience

5 years experience (Sr Specialist)

Job description

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join our Manufacturing team in Limerick. The role focuses on troubleshooting manufacturing processes, developing personnel, and driving CAPA, with emphasis on cGMP compliance and documentation.

You will collaborate across functions to monitor trends, lead technology transfer, and ensure timely completion of validation activities, while maintaining high safety and quality standards.