CQV Manager

Overview

PM GROUP – Who we are

We are an employee owned, international project delivery firm with a team of 4.000+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations, focussing on growing a sustainable business centered around our people, our clients and trade partners.

Due to our ongoing projects in Switzerand, PM Group is seeking to build a team of experienced CQV professionals, ranging from Experienced Professionals to Lead Engineers, to deliver Commissioning, Qualification and Validation services throughout the full project lifecycle.

Responsibilities

• Accountable for delivering scope across the full project lifecycle (Design, Construction, CQV, and Start-up) while operating as a cross-functional workstream lead, ensuring alignment across engineering, quality, operations and vendors.
• Ensure compliance with GMP standards, project timelines, and operational excellence.
• Lead CQV strategy and execution.
• Coordinate system boundary definition, risk assessments, and CQV plans.
• Develop and execute CQV documentation (FAT, SAT, IQ/OQ/PQ).
  Interface with engineering, automation, and operations teams to ensure system integration.
• Drive system start-up readiness and performance verification.
• Ensure ALCOA+ data integrity principles are applied across all CQV activities.
• Develop and execute CQV strategy aligned with regulatory guidance. Define critical process parameters (CPPs) and critical quality attributes (CQAs).
• Integrate CQV activities with manufacturing and quality teams.
• Ensure robust documentation and inspection readiness.

Qualifications

• Degree in Pharmaceutical Science, Electrical or Mechanical Engineering, Process Engineering or related discipline
• 8+ years’ experience of carrying out commissioning and qualification activities on multiple projects in the
• BioPharma/Chemical API’s/Aseptic Processing environment
• Project execution / construction experience in Switzerland
• Expert in GMP compliance and Swiss regulations.
• Excellent organizational skills with an ability to produce quality work, and achieve project deadlines within budget, in accordance with client standards and health and safety procedures.
• High degree of flexibility and adaptability to fulfill the demands of site execution
• Fluent German and English