For one of our clients operating in a GMP-regulated Biopharma, we are seeking an experienced CQV Engineer to support Commissioning, Qualification and Validation activities across GMP systems and equipment.

This is a hands-on contracting role, suited for professionals who are comfortable taking ownership of CQV scopes in complex, fast-paced project environments.

Responsibilities

• Take ownership of CQ execution activities related to the assigned GMP systems
• Complete required onboarding and training, and obtain access to all necessary software tools
• Review and understand defined changes, follow applicable SOPs, and define the CQ strategy, required changes and detailed test protocols
• Maintain full ownership of tasks, schedules and timelines for the relevant systems
• Ensure compliance with project protocols and standards related to:
• Health, Safety and Environmental requirements
• Quality standards, including GDP/GMP
• Commissioning and Qualification activities (IQ, OQ, Commissioning)
• Collaborate closely with vendors, suppliers, contractors and project Automation teams to ensure alignment of activities and timelines
• Proactively contribute to the creation, review and delivery of CQV documentation and outcomes for the assigned systems
• Identify, report and support the resolution of project issues, including management of punch lists and deviations
• Support project risk assessments and evaluate the effectiveness of mitigation strategies
• Effectively prioritize and deliver tasks in a fast-paced, project-driven environment

Profile

• Minimum 4+ years of experience in CQV (IQ, OQ, Commissioning) within the pharmaceutical or biotech industry
• GMP Biopharma experience in designing and execution of IQ/OQ/Qualifying/reQ for Stainless Steel Media and/or Buffer tanks, specifically CIP/SIP, including scope reduction and optimization of CIP/SIP cooldown timelines
• Experience working with PCS / MES systems, preferably in Siemens-based environments
• Exposure to SCADA systems (Siemens PLC preferred)
• Strong understanding of cGMP requirements and FDA / industry expectations
• Excellent troubleshooting and problem-solving skills
• Ability to work autonomously while collaborating effectively with cross-functional teams
• Fluent in English (German and/or French is a plus)