Project Manager (Work Package Lead)

Work Package Owner – Operational Integration & GMP Compliance | Biopharmaceutical / GMP Environment

Company Description

A global biopharmaceutical leader is seeking a Work Package Owner (WPO) – also referred to as Technical Package Lead (TPL) – to support the operational integration of engineering scope items within a mammalian commercial production facility. This critical role serves as the operational focal point at the BioAtrium site, ensuring GMP compliance, documentation readiness, and seamless technical coordination across engineering, quality, and validation teams.

Job Description

As the Work Package Owner, you will be responsible for overseeing the operational integration of mechanical adaptations tied to a defined engineering scope. Acting as the main interface between internal operations and external engineering (EPCM) partners, you will manage project documentation, support GMP change control processes (CRs/TCRs), and ensure readiness across the IQ/OQ/PQ lifecycle. This role requires technical oversight, cross-functional coordination, and hands-on execution across multiple engineering packages.

Key Responsibilities:

• Serve as the operational integration lead for assigned engineering scope items
• Coordinate with EPCM partners and contractors to ensure alignment between execution and GMP compliance
• Maintain and structure documentation (URS, TS, FDS, Risk Analysis, test protocols) in line with quality standards
• Draft and review Change Requests (CRs) and Technical Change Requests (TCRs)
• Act as the technical point of contact for assigned scope items during project delivery
• Ensure quality, safety, and regulatory compliance in collaboration with QA teams
• Support contractor coordination during integration and site activities
• Collaborate with stakeholders across Manufacturing, QA, Engineering, Validation, and Scheduling
• Track progress of scope items against milestones; flag risks and propose mitigations

Essential Requirements:

• Bachelor's degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field
• 3–5 years of experience in GMP-regulated biopharma environments
• Strong understanding of GMP, Change Control, and document management systems (e.g., Veeva, TrackWise)
• Proven ability to work in cross-functional project teams and coordinate with EPCM contractors
• Experience managing technical documentation and compliance throughout IQ/OQ/PQ phases

Desirable Qualifications:

• Advanced degree or project management certification (e.g., PMP)
• German language skills (in addition to English)

Key Competencies:

• Strong organizational and documentation skills
• Effective stakeholder communication and coordination
• Independent, proactive, and detail-oriented working style
• Solid grasp of GMP and operational integration processes

Additional Insights:

Location: BioAtrium site

Department: Engineering / Operational Integration

Language Requirements: English (mandatory), German (advantageous)

Start Date: ASAP

Interested? Please send your CV to Miguel Gomes at [email protected] or reach out directly at +31 20 20 44 502.