Engineering Project Manager - Filling Lines (CAPEX)

Engineering Project Manager - Capex - 7037

Our client is a specialized biotherapeutics manufacturer with over a century of experience in treating various diseases worldwide. They are dedicated to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare conditions.

The Engineering Project Manager will be accountable for delivering local CapEx projects, primarily focused on Fill/Finish processes, from feasibility through planning, execution, and qualification/validation within the framework of the global engineering and project delivery (ENG/PD) department.

The ideal candidate will possess robust technical knowledge in process and infrastructure engineering, along with proven expertise in a cGxP environment. Fluency in both German and English is essential for effective communication with global and local teams within the engineering and project delivery organization. This position is a contract role until the end of the year.

Main Responsibilities

• Oversee project activities required for scoping, developing, procuring, constructing, and qualifying new equipment and facilities to meet production throughput demands.
• Lead multi-disciplinary teams through project lifecycle activities to deliver capacity expansion capabilities in alignment with global and local strategic requirements.
• Develop and maintain integrated project plans while monitoring adherence to milestone timelines, deliverables, and budgets against the approved plan.
• Maintain oversight of project risks and formulate effective risk mitigation strategies.
• Ensure alignment of initiatives with business objectives and strategic philosophy.
• Provide cGMP-compliant processes and facilities suitable for FDA and global regulatory approvals.
• Implement EHS by design principles throughout the project lifecycle.
• Generate regular project reports, including financial updates, project schedules, risks, and summaries of current activities for senior management and global steering committees.
• Steer project teams towards the completion of lifecycle activities through performance qualification.
• Encourage collaborative team dynamics, a customer-focused mindset, and superior performance through personal leadership abilities, mentoring, and effective communication.

Qualifications and Experience

• Relevant working/residency permit or Swiss/EU citizenship required.
• Successful completion of studies in Engineering, Business Administration, or Life Sciences (MS/MBA/BS/BA or equivalent).
• A minimum of 10 years of experience in managing capital projects within the pharmaceutical industry.
• Experience with Annex 1 and filling lines is advantageous.
• Functional knowledge of cGMPs and manufacturing operations in FDA-regulated facilities.
• Excellent understanding of project management principles and lifecycle phases, including validation, CMC, and regulatory submission requirements.
• Experience managing high-level project budgets.
• Ability to handle multiple tasks concurrently and integrate project planning efforts across functions.
• Proactive problem-solving approach with the capacity to see the “big picture.”
• German language skills are beneficial, and excellent proficiency in English communication is required.

Apply online using the form below. Only applications matching the job profile will be considered.