CQV Manager (CAPEX) – 7135

CTC Resourcing Solutions; Oberwallis; On-site; CHF 140,000 - 190,000; Full time

Job summary

CTC Resourcing Solutions seeks a CQV Manager for CAPEX projects in Visp, Switzerland. You will lead CQV protocols for new equipment, facilities and processes, ensuring compliance with regulatory requirements and corporate quality standards.

You will collaborate with engineering, manufacturing, quality and regulatory affairs to integrate CQV activities into the project plan, drive resource planning and budget control, and mentor a global team across remote sites.

Qualifications

• Master's degree in Pharma/Engineering/Science.
• 5-10 years of CQV & Project Management experience.
• Knowledge of cGMP and pharmaceutical/biotech manufacturing.
• Strong leadership and global collaboration skills.

Responsibilities

• Lead a team of engineers and technicians to develop CQV protocols.
• Oversee qualification and validation activities per regulatory standards.
• Collaborate across engineering, manufacturing, quality, and regulatory affairs.
• Manage resource allocation, schedule, and budget for CQV execution.
• Mentor and coordinate cross-site teams across remote offices.
• Define and implement CQV strategies aligned with global standards.

Skills

CQV leadership

Project management

Financial acumen

Global collaboration

Communication skills

Regulatory knowledge

Education

Master Degree in Pharma/Engineering/Science

Job description

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a CQV Manager - CAPEX to be based in Visp, Switzerland for an initial 12 months contract with high chances of extension.

The CQV (Commissioning, Qualification, and Validation) Manager ensure that new equipment, facilities, and processes meet the regulatory requirements and quality standards.

Main Responsibilities:

• Manage and lead a team of engineers and technicians to develop and execute CQV protocols for new equipment, facilities, and processes in compliance with regulatory requirements and corporate quality standards
• Oversee the execution of qualification and validation activities, such as installation and operational qualification, ensuring that all documentation and reports are accurate and complete
• Collaborate with other departments, such as engineering, manufacturing, quality and regulatory affairs, to ensure that CQV activities are integrated into the project plan and completed on time and within budget
• Calculate resource allocation, cost estimation, and timeline projection for successful CQV execution in assigned portfolio of CAPEX projects, ensuring the completion of all tasks within schedule through meetings with team members and resources to highlight and communicate schedule targets, resolve issues, and *escalate* when necessary
• Manage staffing for projects, identify and lead internal or external resources for appropriate project execution
• Oversee several remote offices which will be located in different strategic location across the globe to increase efficiency and to reduce Cost
• Act as subject matter expert (SME) in developing Project Execution Plan and Project Quality Plan and involved committees
• Develop and implement commissioning, qualification, and validation (CQV) strategies aligned with global standards for CAPEX investments portfolio
• Lead CQV activities to ensure compliance with regulatory requirements and industry standards.
• Oversee project plans to ensure timely completion of CQV deliverable.
• Collaborate with cross-functional teams to identify and mitigate risks associated with CAPEX investments
• Provide technical leadership and guidance for CQV activities according to industry standards.
• Develop and maintain relationships with key stakeholders for successful project execution
• Conduct training sessions on CQV principles and best practices, identify opportunities for continuous improvement, and implement changes to optimize CQV processes

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required
• Master Degree in Pharma/Engineering/Science
• 5-10 years of experience with CQV & Project Management
• Comprehensive understanding of Pharmaceutical/Bio Science "Contract Manufacturing" business and experienced in cGMP.
• Comprehensive understanding of Fill and Finish Facility Building and processes.
• Strong leadership skills with a global interaction capability.
• Possess financial and commercial acumen, able to link understanding to project goals, costs & scheduling, and risk.
• Experienced in calculating project-related resource needs, time, and costs.
• Experienced as CQV-Lead and/or Project Manager.
• Mature collaboration and influencing skills, able to work efficiently in a highly matrix environment with teams and individuals.
• Strong analytical skills for in-depth analysis of complex/large datasets, drawing conclusions and supporting decisions.
• Ability to work independently and as part of a team-oriented environment.
• Able to deal with ambiguity, conforming to shifting priorities and demands, prioritize and execute tasks in a fast-paced environment.
• Possess strong written and oral communication skills.
• NEAT Required , Deltav advantage
• Fluent English while German is preferred