Engineering Project Manager – Filling Lines ( CAPEX)

CTC Resourcing Solutions AG seeks a Senior Engineering Project Manager in Bern to lead local CapEX projects for filling and finishing lines, ensuring compliance and timely delivery.

Positioned within the global engineering and project delivery department, this role oversees the full lifecycle of local capital expenditure initiatives in the fill and finish domain. The position is accountable for guiding projects from initial feasibility studies through planning, execution, and final qualification or validation.

Responsibilities

• Manage the end-to-end process of scoping, developing, procuring, constructing, and qualifying new equipment and facilities to satisfy production throughput needs.
• Direct cross-functional teams through all project lifecycle stages to successfully expand capacity capabilities.
• Create and update comprehensive project schedules, tracking progress against milestone dates, deliverables, and budget constraints.
• Identify potential project risks and formulate strategies to mitigate them effectively.
• Align all project initiatives with the broader business objectives and strategic philosophy.
• Ensure that processes and facilities meet cGMP standards and are suitable for FDA and other global regulatory approvals.
• Integrate EHS by design principles into every project phase.
• Prepare and present regular project status reports to senior site management and global steering committees.
• Foster a collaborative team environment and drive superior performance through leadership and mentoring.

Requirements

• Hold a valid working/residency permit or possess Swiss/EU citizenship.
• Have completed studies in Engineering, Business Administration, or Life Sciences (MS/MBA/BS/BA or equivalent).
• Possess at least 10 years of experience managing capital projects within the pharmaceutical industry.
• Demonstrate functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.
• Show excellent understanding of project management principles, including validation, CMC, and facility regulatory submission requirements.
• Have excellent English communication skills.

Nice to have

• Experience with Annex 1 and filling lines.
• German language skills.

About the company

The client is a specialist biotherapeutics manufacturer with over a century of experience. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.

• Specialist biotherapeutics manufacturer with over a century of experience.
• Committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases and other rare diseases.