Manpower Description: Position Overview The Project Engineer plays a critical role in overseeing the successful realization of capital investment projects in a commercial mammalian cell production line. This position bridges technical expertise, operational excellence, and project management to ensure that the investments deliver both the intended mechanical adaptations and operational improvements. The Project Engineer acts as the primary liaison between the operational teams, quality assurance and the Engineering team. Key Responsibilities Project Scope and Strategy Development: ? Define the technical requirements and success criteria for the project, 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 for the project, 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 to ensure seamless integration of mechanical adaptations into production. ? Facilitate communication and alignment between the 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: German Fluent highly preferred - English is required As this is an urgent request, if you believe you are a good fit, please do not hesitate to contact me directly during the day. alba.jansa@experis.ch Branche: Pharmaindustrie Funktion: Personalwesen