wemakeit AG seeks a Senior Engineering Project Manager for CSL Behring in Bern to lead capital projects for pharmaceutical manufacturing facilities.
This position supports CSL Behring, a global leader in biotherapeutics dedicated to saving lives through treatments for immune deficiencies and other critical conditions. The Engineering Project Manager will oversee the end-to-end delivery of new equipment and facility expansions, ensuring they meet strict production, regulatory, and strategic goals.
Responsibilities
- Manage the full lifecycle of capital projects, including scoping, development, procurement, construction, and qualification of new equipment and facilities.
- Lead cross-functional teams to deliver capacity expansion initiatives that align with global and local business strategies.
- Create and maintain integrated project plans, tracking progress against milestone timelines, deliverables, and approved budgets.
- Identify project risks early and develop effective mitigation strategies to ensure smooth execution.
- Ensure all initiatives support the company’s business objectives and strategic philosophy.
- Guarantee that processes and facilities comply with cGMP standards and are suitable for FDA and other global regulatory approvals.
- Implement EHS by design principles throughout project planning and execution.
- Prepare and present regular project reports, including financial updates, schedules, risk assessments, and activity summaries, to senior management and steering committees.
- Oversee project teams through all lifecycle activities up to performance qualification.
- Foster a collaborative, customer-focused environment by mentoring team members and using strong leadership and communication skills.
Requirements
- Degree in Engineering, Business Administration, or Life Sciences (MS, MBA, BS, BA, or equivalent).
- At least 10 years of experience managing capital projects within the pharmaceutical industry.
- Solid understanding of cGMP regulations and manufacturing operations in FDA-regulated facilities.
- Deep knowledge of project management principles, lifecycle phases, Validation, CMC, and facility regulatory submission requirements.
- Proven ability to manage high-level project budgets.
- Strong multitasking skills with the ability to integrate planning efforts across multiple functions.
- Ability to see the big picture and solve problems proactively in a team-oriented manner.
- Fluency in German is mandatory.
Nice to have
- Experience with Annex 1 and filling lines.
- Familiarity with Execution systems.
- Experience using Trackwise.
- Experience using Veeva.
- Experience with Power BI or Clarity.
About the company
wemakeit AG is a recruitment partner that upholds the highest standards of quality, ethics, and discretion in its operations.
- Commitment to the highest standards of quality.
- Strong emphasis on ethical practices.
- Maintaining strict discretion in all professional interactions.
How to apply
Documents to submit:
- CV
- certificates
- training certificates
Quelle: öffentlich zugängliche Karriereseite des Arbeitgebers. Batchly ist nicht der Arbeitgeber und steht nicht notwendigerweise in einem Vertragsverhältnis mit dem Unternehmen.