Senior Engineering Project Manager - GMP – 6655 ASH
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CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a
It is a 12-Month contract based in the Valais area, Switzerland.
The experienced (Senior) Engineering Project Manager ensures the flawless transition from detailed design to construction and qualification of mechanical adaptations within an existing GMP commercial mammalian production line. Requires the capabilities of an Engineering Project Manager to drive design completion to defined deliverables.
Main Responsibilities:
Responsibilities
* Project Management:
* 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.
Compliance & Documentation
* 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 other validation materials.
Resource Management
* Manage project resources, including internal staff and external contractors, to ensure timely delivery.
* Develop and manage the project budget, tracking expenditures and addressing variances proactively.
Performance Qualification (PQ)
* Oversee and coordinate performance qualification (PQ) activities, ensuring the system meets intended operational and regulatory requirements.
* Collaborate with production staff during PQ to validate operational improvements and mechanical adaptations.
Qualifications and Experience
* Relevant working/residency permit or Swiss/EU-Citizenship required
* 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.
* 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.
* English required to communicate with all stakeholders, German is an advantage
* 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.
* Proficiency in project management tools and software (e.g., MS Project, Primavera).
* Strong problem-solving and decision-making capabilities.
* PMP (Project Management Professional) certification is preferred
* Lean Six Sigma or other operational excellence certifications are a plus.
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Engineering and Project Management
Industries
* Pharmaceutical Manufacturing and Biotechnology Research
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