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Job Function:
Project/Program Management GroupJob Sub Function:
Project/Program ManagementJob Category:
ProfessionalAll Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, BelgiumJob Description:
We are seeking a dynamic Senior Manager for Project Engineering in Advanced Therapies to coordinate the management and execution of end-to-end (E2E) technical projects. This pivotal role requires leveraging technical expertise and industry best practices, creates both internal and external partnerships within the Engineering domain of the CAR-T EMEA program, and spans both Beerse and Ghent sites. You will play a vital role in ensuring seamless collaboration between various workstreams, vendors, sites, and stakeholders until handover to operations.
Your focus will be on fostering continuous improvements to enhance efficiency and ensure adherence to schedules. This role also fosters strong collaborations with key stakeholders, like Operations, Engineering & Project Services (E&PS) Project Delivery, and Environment Health & Safety teams.
Key Responsibilities
- Develop and manage the long-term business plan for capital projects, acting as the primary contact for the asset community.
- Develop business cases
- Contribute to the flawless execution and coordination of E2E projects across various domains, including equipment, facilities, utilities, and cleaning & qualification (C&Q).
- Develop, implement, and oversee E2E technical assessments and solution rollouts.
- Proactively identify and resolve technical issues or roadblocks swiftly, incorporating lessons learned.
- Ensure adherence to all applicable current Good Manufacturing Practices (cGMPs), global regulatory requirements, safety and environmental regulations, Standard Operating Procedures (SOPs), Work Instructions (WIs), and corporate policies and standards.
- Cultivate and manage partnerships with contractors and vendors.
- Maintain regular communication with project leads and ensure effective stakeholder management throughout the project lifecycle.
Knowledge/Skills
- At least 10 years of proven experience in project management; experience in the pharmaceutical industry in a sterile environment is a plus.
- Familiarity with international health authority inspections and internal/external audits.
- Strong communication and stakeholder management skills.
- Business acumen, proven experience in Building business cases
- Ability to prioritize tasks under pressure.
- In-depth knowledge of current GMP standards and guidelines related to equipment, utilities, and facilities commissioning and qualification (e.g., ISO, EN, ICH, FDA, ISPE).
- Experience in a large matrix-managed environment is preferred.
- Project Management certification is a plus.
- A proactive team player with a commitment to recognizing Engineering as a service, demonstrated through hands-on engagement in key technical tasks.
Education
- Bachelor's degree in Engineering, Science, or a related discipline; a Master's degree is preferred.
- 10 years of experience in a pharmaceutical plant-based role or consultancy.
Join our team and be a part of the transformative journey in Advanced Therapies! Your expertise will play a crucial role in shaping the future of our projects.
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