Technical Package Lead (m/f/d)
Responsibilities
- Act as BioAtrium’s primary contact for operational integration of assigned engineering scope items
- Coordinate between EPCM partner, contractors, and internal teams to ensure GMP-compliant execution
- Create, update, and structure project documentation (URS, TS, FDS, HAZOP, IQ/OQ/PQ protocols)
- Ensure documentation aligns with internal quality and document control standards
- Draft and review Change Requests (CRs) and Technical Change Requests (TCRs)
- Ensure technical accuracy and GMP compliance in all change-related documentation
- Provide technical oversight for mechanical adaptations and scope-specific activities
- Support EPCM partner in supervising contractors during integration
- Collaborate cross-functionally with Manufacturing, QA, Engineering, Validation, and EPCM teams
- Track progress of scope items against project milestones and propose mitigation strategies for delays
Profile
- Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field
- Advanced degree or project management certification (e.g., PMP) advantageous
- Solid experience in biopharma or GMP-regulated environments
- Strong understanding of GMP principles and change control processes
- Familiarity with document management systems (e.g., Veeva, TrackWise)
- Experience working in cross-functional teams and with external contractors or EPCM providers
- Ability to manage multiple priorities under strict timelines
- Excellent organizational and documentation skills
- Strong communication and stakeholder engagement abilities
- Hands-on, solution-oriented, and proactive mindset
Benefits
- Opportunity to lead scope-specific initiatives in a cutting-edge biopharma environment
- Exposure to complex GMP-regulated processes and international standards
- Cross-functional collaboration with experts in manufacturing, engineering, and quality
- Professional development through technical ownership and project leadership
- Dynamic and supportive team culture focused on innovation and compliance
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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