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:
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Health, Safety and Environmental requirements
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Quality standards, including GDP/GMP
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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)