Project Scope and Strategy Development : * Define 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. * Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements. * 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 EPCM to address any technical challenges or deviations. Project Execution and Monitoring : * Monitor 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 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 and Experience : * Relevant working / residency permit or Swiss / EU-Citizenship required * Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field. * 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. * 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.