Main Responsibilities:
Operational Integration Lead: Act as primary point of contact for the operational integration of the assigned engineering scope items, ensuring seamless coordination between technical execution (external engineering (EPCM) partner & contractors) and GMP compliance.
Document Management: Maintain, create or update, and structure project-related documentation (URS, TS, FDS, Risk Analysis (HAZOP), technical bid reviews, IQ/OQ/PQ test protocols, etc.) for each scope item in alignment with internal quality and document control standards.
Change Management: Contribute to drafting and reviewing of Change Requests (CRs) and Technical Change Requests (TCRs), ensuring technical content accuracy and alignment with GMP requirements.
Technical Oversight: Act as the primary technical point of contact for the assigned scope items, ensuring all mechanical adaptations and operational integration activities meet required specifications. Coordinate with EPCM scope lead / working team to ensure alignment of engineering deliverables with technical and operational requirements. Quality and Compliance
Oversight: In cooperation with internal QA team, ensure that all project activities comply with internal and regulatory GMP regulations and internal quality standards and that proper documentation is available for inspections and audits.
Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
Contractor Oversight: Despite the fact, that contractor oversight is with engineering (EPCM) partner, WPO supports them in coordinating and supervising the work of contractors and workshop staff during on-site integration activities, ensuring that work is executed according to plan, timeline, and safety standards.
Stakeholder Coordination: Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, Validation, and EPCM teams to align on timelines, priorities, and operational readiness.
Schedule and Progress Tracking: Support engineering (EPCM) partner’s and schedulers in monitoring progress of assigned scope items against project milestones. Identify risks or delays early and propose mitigation strategies.
Qualifications and Experience:
·Relevant working/residency permit or Swiss/EU-Citizenship required
·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 management systems (e.g., Veeva, TrackWise).
·Experience working in cross-functional project teams and coordinating with external contractors or EPCM providers.
·Proven ability to manage multiple priorities under strict timelines in a regulated environment.
Key Competencies
·Excellent organizational and documentation skills
·Strong communication and stakeholder engagement
·Hands-on, solution-oriented, and proactive mindset
·Ability to work independently and lead scope-specific initiatives
·Detail-oriented with a solid grasp of GMP and operational requirements
·English mandatory / German a real plus