CQV Manager

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

Lead CQV activities for major biopharmaceutical CAPEX projects, ensuring regulatory compliance, technical excellence and successful project delivery.

CQV Manager

Job description:

We are looking for an experienced Manager, Project Engineering – CQV to lead Commissioning, Qualification and Validation (CQV) activities across a portfolio of biopharmaceutical CAPEX projects in Visp, Switzerland.

In this role, you will combine technical expertise, project management and team leadership to ensure that facilities, equipment and manufacturing processes are commissioned and qualified in accordance with GEP/cGMP requirements, quality standards, project schedules and budgets.

Key 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.

About the customer:

Our client is a leading global organization in the life sciences and biopharmaceutical manufacturing industry, specializing in the development and production of innovative pharmaceutical products. Operating in a highly regulated environment, the organization invests in state-of-the‑art manufacturing facilities and advanced technologies to support complex biopharmaceutical processes.

Requirements:

• Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences or a related technical discipline.
• Approximately 8–15 years of professional 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.

Nice to Have

• Experience with DeltaV automation systems.
• Business‑fluent German.
• Experience coordinating geographically distributed engineering and CQV teams.
• Demonstrated success in standardizing CQV processes and driving continuous improvement initiatives.

Compensation benefits:

• Contract duration of approximately 12 months, with the possibility of extension.
• Opportunity to contribute to significant biopharmaceutical CAPEX investments.
• Exposure to complex engineering projects within an international, highly regulated manufacturing environment.