Engineering Project Manager / Technical Lead - EU Annex 1 - GMP - Fluent English & German

LHH; Bern; Vor Ort; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

A leading company in Switzerland is seeking a Technical Lead to support engineering projects in GMP-regulated environments. The role involves technical coordination, risk assessments, and documentation, ensuring compliance with internal and external standards. Proficiency in English and German is essential, along with at least 5 years of relevant experience.

Qualifikationen

• Minimum 5 years of experience in GMP-regulated environments.
• Fluency in English and German.
• Solid understanding of cGMP, EU Annex 1, and engineering documentation.

Aufgaben

• Lead technical coordination for projects ensuring compliance with GMP.
• Conduct risk assessments including FMEA and design reviews.
• Author and review project-related documentation.

Kenntnisse

Technical troubleshooting

Project management

Risk assessment

Strong communication

Organizational skills

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.

• Where prescribed and required, wear protective equipment consistently and replace when defective.
• Eliminating hazards and risks immediately where possible, otherwise report them to supervisor immediately.
• 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.
• Preferably on - site presence for coordination, with up to 40% flexibility for home office.
• Act as a technical liaison and support contact for operators.
• Support training sessions and information briefings for shopfloor personnel.
• Fluent in English (written and spoken) & German language skills are necessary
• 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.

LI-Hybrid