CQV Program Lead for Biopharma CAPEX

Swisslinx AG; Zürich; On-site; CHF 140,000 - 190,000; Full time

Benefits offered by this job

Contract duration 12 months

International project exposure

Opportunity for extension

Job summary

Swisslinx AG seeks an experienced CQV Manager to lead Commissioning, Qualification and Validation activities for biopharmaceutical CAPEX projects in Visp, Switzerland. You will drive CQV strategies, coordinate multi‑location teams and ensure CQV activities meet regulatory and quality standards.

Key responsibilities include managing IQ/OQ, validation protocols, budgets and schedules, while collaborating with Engineering, Manufacturing, Quality and Regulatory Affairs to deliver safe, compliant

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences or related field.
• 8–15 years of professional experience in pharmaceutical/biopharmaceutical engineering environments.
• Proven experience delivering CAPEX projects within GEP/GMP-regulated biopharmaceutical facilities.
• Demonstrated experience leading CQV projects or programs.
• Strong knowledge of cGMP requirements, pharmaceutical contract manufacturing and fill‑finish facilities and processes.
• Solid project management capabilities, including resource planning, cost estimation, scheduling, risk management and stakeholder coordination.
• Hands‑on experience with NEAT.
• Business‑fluent English.

Responsibilities

• Develop and implement CQV strategies, execution plans and quality plans for CAPEX investments.
• Lead multidisciplinary teams of engineers, technicians and project resources across locations.
• Manage resource allocation, budgets, schedules and milestones, identifying risks and implementing corrective actions.
• Oversee commissioning, IQ, OQ and other validation activities.
• Ensure preparation, execution and review of qualification protocols, documentation and reports.
• Collaborate with Engineering, Manufacturing, Quality and Regulatory Affairs to integrate CQV activities into project execution.
• Act as SME for CQV and support governance and risk mitigation.
• Drive continuous improvement through process standardization and knowledge sharing.

Skills

Analytical skills

Problem solving

Communication

Stakeholder management

Project management

NEAT

Education

Master's degree in Engineering/Pharmaceutical Sciences/Life Sciences

Tools

DeltaV

Job description

Swisslinx AG seeks an experienced CQV Manager to lead Commissioning, Qualification and Validation activities for biopharmaceutical CAPEX projects in Visp, Switzerland. You will drive CQV strategies, coordinate multi‑location teams and ensure CQV activities meet regulatory and quality standards.

Key responsibilities include managing IQ/OQ, validation protocols, budgets and schedules, while collaborating with Engineering, Manufacturing, Quality and Regulatory Affairs to deliver safe, compliant