Technical Package Lead

Join 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.

Key Skills and Requirements:

• 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.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

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