CQV Program Lead - Biopharma CAPEX Projects

Swisslinx AG; Oberwallis; On-site; CHF 150,000 - 210,000; Full time

Job summary

Swisslinx AG seeks an experienced Manager, Project Engineering – CQV to lead CQV activities for biopharma CAPEX projects in Visp, Switzerland. You will combine technical expertise, project management and leadership to ensure facilities and processes are commissioned and qualified in line with cGMP standards.

The role requires 8–15 years in pharma/biopharma engineering, proven CQV leadership, and strong English in a global, regulated environment.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences or related discipline.
• 8–15 years of experience in pharmaceutical or biopharmaceutical engineering environments.
• Proven experience delivering CAPEX projects within GEP/GMP-regulated biopharmaceutical facilities.
• Demonstrated experience leading Commissioning, Qualification and Validation (CQV) projects or programs.
• Strong knowledge of cGMP requirements, pharmaceutical contract manufacturing and fill-and-finish facilities and processes.
• Solid project management capabilities, including resource planning, cost estimation, scheduling, risk management and stakeholder coordination.
• Hands-on experience with NEAT (mandatory).
• Proven ability to lead multidisciplinary teams and operate effectively within global, matrixed organizations.
• Strong analytical, problem-solving, communication and stakeholder management skills.
• Sound financial and commercial judgment, adaptability and a proactive approach to quality and safety.
• Business-fluent English.

Responsibilities

• Develop and implement CQV strategies, execution plans and quality plans for CAPEX investments, ensuring alignment with global standards and regulatory requirements.
• Lead and coordinate multidisciplinary teams of engineers, technicians and internal/external project resources across multiple locations.
• Manage resource allocation, budget estimations, project schedules and milestones, identifying risks and implementing corrective actions where necessary.
• Oversee commissioning, Installation Qualification (IQ), Operational Qualification (OQ) and other relevant validation activities.
• Ensure the preparation, execution and review of accurate and compliant qualification protocols, documentation and reports.
• Collaborate closely with Engineering, Manufacturing, Quality and Regulatory Affairs to integrate CQV activities into overall project execution.
• Act as a Subject Matter Expert (SME) for CQV, providing technical guidance and supporting project governance and risk mitigation.
• Drive continuous improvement through process standardization, training, knowledge sharing and cross-functional collaboration.

Skills

Project management

Leadership

Stakeholder management

Analytical skills

Communication

Education

Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences or related

Tools

DeltaV

NEAT

Job description

Swisslinx AG seeks an experienced Manager, Project Engineering – CQV to lead CQV activities for biopharma CAPEX projects in Visp, Switzerland. You will combine technical expertise, project management and leadership to ensure facilities and processes are commissioned and qualified in line with cGMP standards.

The role requires 8–15 years in pharma/biopharma engineering, proven CQV leadership, and strong English in a global, regulated environment.