Position Overview
The Project Engineer plays a critical role in overseeing the successful realization of capital investment projects within a commercial mammalian cell production line. This position requires a blend of technical expertise, operational excellence, and project management skills to ensure that investments achieve their intended mechanical adaptations and operational improvements. The Project Engineer serves as the primary liaison among operational teams, quality assurance, and the engineering team.
Key Responsibilities
- Project Scope and Strategy Development:
- Define technical requirements and success criteria, ensuring alignment with GMP standards, operational goals, and compliance expectations.
- Collaborate with stakeholders to integrate operational improvements into the overall project plan.
- Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).
- Technical Leadership:
- Act as the primary technical point of contact, ensuring all mechanical adaptations and operational improvements meet required specifications.
- Provide guidance and support to production staff implementing operational improvements.
- Quality and Compliance Oversight:
- Ensure that all project activities comply with GMP regulations and internal quality standards.
- Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
- Cross-Functional Coordination:
- Liaise with operations, maintenance, engineering, and quality teams for seamless integration of mechanical adaptations into production.
- Facilitate communication and alignment between production staff and the Engineering Partner to address any technical challenges or deviations.
- Project Execution and Monitoring:
- Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
- Conduct risk assessments and develop mitigation plans for potential project roadblocks.
- Provide regular updates and technical reports to project stakeholders.
- Testing and Qualification:
- Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
- Oversee and coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes.
Qualifications
- Education: Bachelor's or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
- Experience:
- 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
- Proven experience working on GMP-compliant projects, including change management and qualification activities.
- Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
- Skills:
- Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
- Proficiency in project management tools and methodologies.
- Excellent problem-solving skills with the ability to manage technical challenges in a fast-paced environment.
- Effective communication and interpersonal skills to coordinate cross-functional teams.
- Detail-oriented with strong organizational skills for managing multiple workstreams.
- Language: Fluency in German is highly preferred; proficiency in English is required.
Apply online using the form below. Only applications matching the job profile will be considered.