Driving GMP-compliant innovation-turning complex CAPEX projects into high-performing biopharma solutions.
Proclinical is seeking a Project Engineer (CAPEX) to support capital investment projects within a commercial mammalian cell production line. This role focuses on ensuring mechanical adaptations and operational improvements align with GMP standards and project goals. You will act as a key liaison between operational teams, quality assurance, and engineering, driving technical excellence and compliance throughout the project lifecycle.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Define technical requirements and success criteria for projects, ensuring alignment with GMP standards and operational goals.
- Collaborate with stakeholders to integrate operational improvements into project plans.
- Develop comprehensive roadmaps for project lifecycles, from conceptual design to performance qualification (PQ).
- Serve as the primary technical point of contact, ensuring mechanical adaptations meet specifications.
- Provide guidance to production staff implementing operational improvements.
- Ensure all project activities comply with GMP regulations and internal quality standards.
- Manage GMP change control processes, including preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
- Coordinate with operations, maintenance, engineering, and quality teams for seamless integration of mechanical adaptations.
- Facilitate communication between production staff and engineering partners to address technical challenges.
- Monitor project progress to ensure milestones are met on time and within budget.
- Conduct risk assessments and develop mitigation plans for potential roadblocks.
- Lead equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
- Oversee validation teams to ensure reliability and effectiveness of implemented changes.
Key Skills and Requirements:
- Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
- Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
- Proficiency in project management tools and methodologies.
- Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
- Effective communication and interpersonal skills for cross-functional coordination.
- Detail-oriented with strong organizational skills to manage multiple workstreams.
- Problem-solving skills to address technical challenges in a fast-paced environment.
- Fluency in English is required; German fluency is highly preferred.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
Apply Now:
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