- Company Name
- In-Genium
- Job Title
- Chef de projet pharmaceutique (H/F)
- Job Description
-
**Job Title:**
Pharmaceutical Project Engineer (Project Manager) – Production & Packaging Equipment
**Role Summary:**
Lead the engineering aspects of a strategic expansion and modernization project for pharmaceutical manufacturing facilities. Own the process from gathering user requirements to equipment commissioning, ensuring compliance with GMP/BPF, safety standards, budget, and schedule while coordinating cross‑functional technical and operational teams.
**Expactations:**
- Deliver all project milestones on time, within budget, and to quality standards.
- Ensure full regulatory and GMP compliance throughout the project lifecycle.
- Maintain clear, up‑to‑date project documentation and facilitate smooth hand‑over to operations.
- Effectively manage internal stakeholders, external contractors, and suppliers.
**Key Responsibilities:**
- Capture and formalize user needs; write User Requirement Specifications (URS) for supplier tenders.
- Lead technical offer evaluation, ensuring alignment with GMP/BPF and regulatory requirements.
- Participate in supplier selection, negotiations, and contract finalization with procurement.
- Oversee design, installation, and commissioning of production and packaging equipment (e.g., granulators, coating turbines, tablet presses, automated blister lines).
- Coordinate external contractors, monitor construction progress, and integrate activities into the overall project schedule.
- Manage Commissioning & Qualification (C&Q) activities with dedicated teams.
- Ensure adherence to safety, quality, timeline, and budget constraints.
- Control project documentation, change management, and knowledge transfer to operations.
**Required Skills:**
- Proven project management experience in pharmaceutical equipment engineering (5+ years).
- Strong knowledge of GMP/BPF, validation, and regulatory standards.
- Ability to write and review URS, technical specifications, and qualification protocols.
- Experience with supplier evaluation, negotiation, and contract management.
- Proficiency in project planning tools (MS Project, Primavera) and risk management.
- Excellent communication, leadership, and stakeholder‑management skills.
- Fluency in English (written and spoken); French language skills advantageous.
**Required Education & Certifications:**
- Bachelor’s or Master’s degree in Mechanical, Chemical, Pharmaceutical, or related engineering discipline.
- Project Management Professional (PMP) or equivalent certification preferred.
- GMP/Validation training or certification.
- Relevant safety or quality certifications (e.g., ISO 9001, ISO 13485) desirable.