GMP-CapEx Engineering Project Leader

GXP CONSULTING Switzerland; Bern; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

Competitive salary

International environment

Continuous learning

Zusammenfassung

GXP CONSULTING Switzerland is seeking an Engineering Project Manager to lead end-to-end CapEx projects in a GMP-regulated manufacturing environment. You will partner with EPCM, manufacturing, QA, and validation teams to deliver on time and within budget.

The role requires 6-8+ years in engineering project management, a degree in Engineering or Biotechnology, and fluency in German and English. You will drive continuous improvement, risk management, and compliant documentation across the project

Qualifikationen

• 6-8+ years of engineering project management experience.
• CapEx project delivery from concept through qualification.
• Experience in biopharmaceutical GMP manufacturing.
• Strong cross-functional leadership and multi-disciplinary teams.
• Excellent communication across engineering, manufacturing, QA, and validation.
• Fluency in German and English.

Aufgaben

• Lead engineering projects end-to-end from conceptual design through execution, qualification, and handover.
• Define and manage project scope, objectives, deliverables, timelines, resources, and budgets including contract amendments/claims.
• Lead and coordinate EPCM partners, contractors, and internal engineering teams for timely delivery.
• Act as the key engineering interface between Engineering, Manufacturing, QA, Validation, and other stakeholders.
• Ensure engineering solutions are aligned with customer needs.
• Oversee engineering design, procurement, construction, installation, commissioning, and project close-out activities.
• Drive GMP compliance throughout the project lifecycle and manage GMP change control processes (TCRs/CRs).
• Identify and actively manage project risks, technical issues, dependencies, and opportunities.
• Coordinate with Quality and Validation teams to ensure commissioning, PQ readiness.
• Monitor project performance against scope, schedule, cost, quality, and safety objectives.
• Provide clear project reporting and recommendations to management for timely decisions.
• Ensure robust technical documentation and a smooth transition to manufacturing operations.

Kenntnisse

Project management

Capex projects

GMP compliance

Cross-functional leadership

Biopharma manufacturing

MS Project

Primavera

Stakeholder management

Quality assurance

German-English fluency

Ausbildung

Engineering degree

Biotechnology degree

Tools

MS Project

Primavera

Jobbeschreibung

GXP CONSULTING Switzerland is seeking an Engineering Project Manager to lead end-to-end CapEx projects in a GMP-regulated manufacturing environment. You will partner with EPCM, manufacturing, QA, and validation teams to deliver on time and within budget.

The role requires 6-8+ years in engineering project management, a degree in Engineering or Biotechnology, and fluency in German and English. You will drive continuous improvement, risk management, and compliant documentation across the project