Technical Package Lead
- Schweiz
- Freiberuflich
- Vollzeit
- Job type:
Manufacturing * Location:
SwitzerlandVisp, SwitzerlandPosting date: 07 Aug 2025Reference: 66570Join a dynamic team at a leading Contract Manufacturing Organisation (CMO) and contribute to groundbreaking projects and cutting-edge solutions.Proclinical is seeking a Technical Package Lead to focuses on supporting the integration of mechanical adaptations within a biologics commercial production line. It emphasizes GMP compliance, documentation management, and cross-functional collaboration.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:
- Serve as the main operational point of contact for assigned engineering scope items, ensuring coordination between technical execution, contractors, and GMP compliance.
- Manage and maintain project-related documentation, including URS, TS, FDS, Risk Analysis, HAZOP, technical bid reviews, and IQ/OQ/PQ test protocols.
- Draft and review Change Requests (CRs) and Technical Change Requests (TCRs), ensuring alignment with GMP requirements.
- Oversee technical aspects of mechanical adaptations, ensuring compliance with specifications and operational needs.
- Collaborate with internal QA teams to ensure adherence to GMP regulations and prepare documentation for inspections and audits.
- Support contractor coordination during on-site integration activities, ensuring safety and timeline adherence.
- Work closely with cross-functional teams, including Manufacturing, Quality Assurance, Engineering, Validation, and EPCM partners, to align on priorities and timelines.
- Monitor progress against project milestones, identify risks or delays, and propose mitigation strategies.
- Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field; advanced qualifications or PMP certification are a plus.
- Experience in biopharma or GMP-regulated environments, particularly in manufacturing, engineering, or project execution roles.
- Strong understanding of GMP principles, Change Control processes, and document management systems (e.g., Veeva, TrackWise).
- Proven ability to manage multiple priorities under strict timelines in a regulated environment.
- Excellent organizational and documentation skills.
- Strong communication and stakeholder engagement abilities.
- Hands-on, proactive, and solution-oriented mindset.
- Detail-oriented with a solid grasp of GMP and operational requirements.
- English proficiency is mandatory; German language skills are a plus.