Manufacturing Process Excellence Specialist

Regeneron Pharmaceuticals, Inc; Limerick; Híbrido; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join Manufacturing.

You will apply cGMP expertise, resolve process issues, and support compliance and continuous improvement across production operations. The role emphasizes coaching manufacturing personnel, leading investigations, technology transfer, and cross‑functional collaboration with Process Science and Tech Transfer teams.

Formación

• 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

Responsabilidades

• 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

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join Manufacturing.

You will apply cGMP expertise, resolve process issues, and support compliance and continuous improvement across production operations. The role emphasizes coaching manufacturing personnel, leading investigations, technology transfer, and cross‑functional collaboration with Process Science and Tech Transfer teams.