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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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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