We are looking for a
Senior Engineering Project Manager
with a strong background in GMP-regulated environments to lead the transition from detailed design to construction and qualification of mechanical adaptations within an existing commercial mammalian production line. This role is critical to ensuring design integrity, regulatory compliance, and seamless execution across all project phases.
Responsibilities
Project Leadership & Execution
* Drive the completion of detailed design in alignment with project scope, GMP standards, and defined deliverables.
* Safeguard design intent throughout all phases—from basic design to execution.
* Review and approve technical documentation, drawings, and equipment specifications to ensure constructability and quality.
* Manage project scope, schedule, budget, and risks, including change control processes (TCRs, CRs).
* Coordinate design efforts across EPCM partners, internal engineering, QA, and operations.
* Support procurement of long-lead equipment to align with construction timelines.
Compliance & Documentation
* Ensure full compliance with GMP regulations, internal policies, and industry standards.
* Partner with QA to guarantee regulatory alignment of all project deliverables.
* Maintain thorough documentation including risk assessments, design reviews, and qualification records.
Resource & Budget Management
* Lead internal and external project teams to ensure timely and efficient execution.
* Develop and manage project budgets, monitor expenditures, and address variances proactively.
Performance Qualification (PQ)
* Oversee PQ activities to confirm systems meet operational and regulatory expectations.
* Collaborate with production teams to validate mechanical adaptations and process improvements.
Must-Haves
Education & Experience
* Bachelor's degree in Mechanical, Process, Chemical Engineering or related field (Master's preferred).
* 5–7 years of project management experience in biopharma or regulated manufacturing.
* Proven success managing GMP-compliant engineering projects from design through qualification.
* Experience working with EPCM contractors and cross-functional teams.
Certifications (Preferred)
* PMP (Project Management Professional).
* Lean Six Sigma or other operational excellence certifications.
Location:
Visp
Duration:
12 months
Start date:
ASAP
If you want to learn more about this opportunity please feel free to reach out directly to
*While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.