Jobdetails Operational Integration Lead The Operational Integration Lead, also known as Technical Package Lead (TPL) is a key role in the successful operational integration of mechanical changes to an existing commercial production line. Key Responsibilities:...• Act as the primary point of contact for the operational integration assigned engineering scope items, ensuring seamless coordination between technical execution (external engineering partner) and GMP compliance.• Maintain, create or update, and structure project-related documentation (Risk Analysis, technical bid reviews, IQ/OQ/PQ test protocols) for each scope item • Contribute to drafting and reviewing of Change Requests (CRs) and Technical Change Requests (TCRs)Act as the primary technical point of contact for the assigned scope items, ensuring all mechanical adaptations and operational integration activities meet required Clients specifications• In cooperation with internal QA team, ensure that all project activities comply with internal and regulatory GMP regulations Qualifications• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
Advanced degree or project management training (e.g.
PMP) is a plus.• Minimum 3–5 years of experience in biopharma or GMP-regulated environments, ideally in manufacturing, engineering, or project execution roles.• Strong understanding of GMP principles, Change Control processes, and document managementsystems (e.g., Veeva, Track Wise).• Experience working in cross-functional project teams and coordinating with external contractors• English mandatory / German a real plusmehr anzeigen Operational Integration Lead The Operational Integration Lead, also known as Technical Package Lead (TPL) is a key role in the successful operational integration of mechanical changes to an existing commercial production line. Key Responsibilities:• Act as the primary point of contact for the operational integration assigned engineering scope items, ensuring seamless coordination between technical execution (external engineering partner) and GMP compliance.• Maintain, create or update, and structure project-related documentation (Risk Analysis, technical bid reviews, IQ/OQ/PQ test protocols) for each scope item • Contribute to drafting and reviewing of Change Requests (CRs) and Technical Change Requests (TCRs)Act as the primary technical point of contact for the assigned scope items, ensuring all mechanical adaptations and operational integration activities meet required Clients specifications• In cooperation with internal QA team, ensure that all project activities comply with internal and regulatory GMP regulations Qualifications...• Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field.
Advanced degree or project management training (e.g.
PMP) is a plus.• Minimum 3–5 years of experience in biopharma or GMP-regulated environments, ideally in manufacturing, engineering, or project execution roles.• Strong understanding of GMP principles, Change Control processes, and document managementsystems (e.g., Veeva, Track Wise).• Experience working in cross-functional project teams and coordinating with external contractors• English mandatory / German a real plusmehr anzeigen