Sr. Quality Engineer - CQV

Your new role

In this role, you will play a key part in ensuring that all systems, equipment, and processes supporting manufacturing operations meet the highest quality and compliance standards. As Sr. Quality Engineer I, you provide quality oversight for CQV activities and support the introduction, validation, and continuous improvement of critical systems within their GMP regulated manufacturing site.

Your Responsibilities

As Sr. Quality Engineer I, you will:

Provide quality oversight for CQV and engineering‑related projects, ensuring compliance with internal procedures and regulatory expectations.
Support the introduction of new systems by acting as a technical resource and delivering subject‑matter expertise through commissioning and qualification activities.
Develop and apply risk‑based validation strategies for site‑impacting projects and changes, in alignment with the Site Validation Master Plan.
Review and approve all CQV deliverables, including initial qualification packages, change‑based validations, and periodic requalification documentation.
Contribute to process improvements by developing strategies to implement changes in a controlled and compliant manner.
Perform a broad range of quality activities to maintain compliance with GMP and GLP requirements.
Identify deviations or non‑conformities, assess impact, and support development of appropriate solutions for complex issues.
Partner with operational teams to ensure readiness for inspections, ongoing statistical process control, and internal/external audits.
Support compliance audits when required and ensure documentation and systems always remain inspection‑ready.

What you will need to succeed

Minimum BSc in a Life Sciences related field; Engineering, Pharma.
Minimum 5 years of relevant experience in CQV, Validation, or Quality Engineering roles.
Strong experience in CQV (Commissioning, Qualification, Validation) within a GMP-regulated pharmaceutical or biotech environment.
Ability to provide quality oversight for engineering, equipment, and validation activities.
Proven experience reviewing and approving IQ/OQ/PQ protocols, validation plans, reports, and change control documentation.
Hands-on understanding of technology transfer processes, including new system introduction and equipment startup.
Ability to collaborate effectively across Quality, Engineering, Manufacturing, and QC functions.
Strong analytical and problem‑solving abilities to address complex validation or quality issues.
Solid working knowledge of GMP, GLP, and Quality Systems in a regulated environment.
Experience applying risk management tools (e.g., FMEA, HACCP) in validation and change assessments.
Strong technical writing and documentation skills, particularly for regulatory-compliant documentation.
Ability to work independently, prioritize workload, and execute tasks with minimal direction.

What you’ll get in return
Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, you will get a competitive salary (€89,000) and your travel expenses are covered.

Your new company
Our client is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. They have been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients. With their brand-new production site in Hoofddorp, they are dreaming big. Now you can get the chance to be a part of this journey.

What you need to do now
If you are interested in this role as Sr Quality Engineer I, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.

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