Engineering Project Manager
Bern
Contract
Negotiable
Quality
CR/560406_1758270585
Engineering Project Manager
We have a current opportunity for a Engineering Project Manager on a contract basis. The position will be based in Kanton Wallis. For further information about this position please apply.
Position Overview
Senior Engineering Project Manager to ensure the flawless transition from detailed design to construction and qualification of mechanical adaptations within an existing GMP commercial production line. engineering project manager to drive design completion to defined deliverables.
Key Responsibilities:
- Drive completion of detailed design in line with defined deliverables, project scope, and GMP requirements.
- Ensure design intent is maintained through all phases (basic design → detailed design → execution).
- Review and approve design documents, drawings, and equipment specifications to confirm technical quality and constructability.
- Monitor and control project scope, schedule, cost, and risk, including change management (TCRs, CRs).
- Facilitate design coordination between EPCM, internal engineering teams, quality assurance and operations.
- Support procurement activities (long-lead equipment) to ensure alignment with design and construction sequencing.
- Ensure adherence to GMP regulations, company policies, and industry standards throughout the project lifecycle.
- Collaborate with quality assurance teams to ensure project deliverables meet all regulatory requirements.
- Maintain comprehensive project documentation, including risk assessments, design reviews, and performance qualification (PQ) records.
- Manage project resources, including internal staff and external contractors, to ensure timely and efficient project execution.
- Develop and manage the project budget, tracking expenditures and addressing variances proactively.
- Oversee and coordinate performance qualification (PQ) activities, ensuring the system meets intended operational
- Collaborate with production staff during PQ to validate operational improvements and mechanical adaptations
Key Requirement:
- Bachelor's degree in Engineering (Mechanical, Process, Chemical, or related field). Master's degree is a plus
- Minimum of 5-7 years of experience in project management within a biopharmaceutical or regulated manufacturing environment
- Proficiency in project management tools and software (e.g., MS Project, Primavera)
- Proven track record of managing GMP-compliant engineering projects from design to qualification
- Experience working with EPCM contractors and cross-functional teams, including operations and quality assurance
- Fluent in English required to communicate with all stakeholders, German Advantageous
- Strong project management skills, including budgeting, scheduling, and risk management
- Excellent knowledge of GMP regulations and change management protocols (TCRs and CRs)
- Exceptional communication and stakeholder management skills
- Strong problem-solving and decision-making capabilities
- PMP (Project Management Professional) certification
- Lean Six Sigma or other operational excellence certifications are a plus
(Please note: Only candidates with the legal right to work in Switzerland will be considered. Unfortunately, we are unable to offer permit sponsorship for this role)