Technical Lead / Engineering Project Manager

Gi Life Sciences Basel; Bern; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

A leading company in life sciences is seeking a Technical Lead in Bern for a duration of one year, with responsibilities involving technical coordination, compliance with GMP standards, and acting as a liaison across departments. Ideal candidates will hold a degree in Engineering and possess substantial experience within GMP environments.

Qualifikationen

• Minimum 5 years of experience in technical project execution within GMP-regulated environments.
• Solid understanding of cGMP, EU Annex 1, and engineering documentation.
• Strong communication skills, fluent in English and German.

Aufgaben

• Lead and conduct risk assessments, including FMEA and design reviews.
• Support compliance of manufacturing systems with GMP standards.
• Drive the technical development of solutions for process compliance.

Kenntnisse

Communication

Organizational Skills

Technical Troubleshooting

Ausbildung

Bachelor's or Master's degree in Engineering

Jobbeschreibung

The Technical Lead supports the CAPEX Project Manager by taking the lead in technical coordination activities across cross-functional teams. The role involves ensuring that all technical deliverables are designed, written, reviewed, approved and executed in accordance with internal engineering standards and regulatory expectations. The candidate acts as the key technical contact point for all involved stakeholders and external partners, contributing to the successful and compliant execution of engineering and qualification projects in GMP-regulated environments.

Tasks and responsibilities

• Conduct and lead risk assessments, including FMEA and design reviews
• Support Annex 1 related projects and contribute to ensuring compliance of manufacturing systems with GMP and internal standards
• Drive the technical development of solutions to ensure process and equipment compliance
• Author and review project related documents including URS, URB, and project descriptions
• Review and align external supplier deliverables with internal engineering and quality standards
• Serve as the technical point of contact between departments including Sterility Assurance (SA), Quality Assurance (QA), Production (PRO), Process Engineering (PE), and Project Delivery (PD)
• Lead and participate in project meetings, ensuring technical topics are clarified, documented, and followed up
• Represent the technical function in cross-functional workshops and ensure alignment on technical decisions
• Provide technical support during plant shutdown periods, including preparation, execution, and post-shutdown evaluations
• Act as a technical liaison and support contact for operators
• Support training sessions and information briefings for shopfloor personnel

Candidate profile

• Bachelor's or Master's degree in Engineering (e.g. Mechanical, Electrical, Process, Chemical)
• Minimum 5 years of experience in technical project execution within GMP-regulated environments (pharmaceutical, biotech or life sciences)
• Solid understanding of cGMP, EU Annex 1 and engineering documentation
• Proven experience in FMEA, technical troubleshooting, and interfacing with multiple departments
• Strong communication and organizational skills, with the ability to proactively drive tasks and deliverables
• Fluent in English (written and spoken) and German language skills are necessary

General information

• Planned duration : planned for 1 year (an extension may be possible afterwards)
• Work location : Bern

If you are interested in this position, please send your CV in English.