Commissioning, Qualification, and Validation (CQV) Engineer

About the role

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

This is a hands-on commissioning, qualification and validation role with high growth potential. You will work alongside our CQV Lead on facility, utility and equipment qualification programs for pharmaceutical and biotechnology clients — writing and executing protocols, working in the field, and building toward owning systems independently. We are looking for someone with real GMP experience who wants to move further into validation than their current role allows.

Candidates currently living within commutable distance to Lancaster, PA are encouraged to apply.

Responsibilities

• Author and execute commissioning and qualification protocols — IQ, OQ and PQ — for utilities, equipment and facilities.
• Perform field verification and walkdowns against P&IDs, and log discrepancies for resolution.
• Execute qualification sampling programs and maintain complete, accurate records — sample logs, chain of custody and executed protocols.
• Write deviation reports and summary reports, and support investigations.
• Support risk assessments and FMEAs, and the sampling plans that follow from them.
• Support change control, and help close out qualification packages.
• Work with client engineering and quality teams on site, representing Eurofins professionally.
• As you grow: take ownership of systems end to end, mentor newer engineers, and lead your own qualification workstreams.

Qualifications

• Two or more years of hands-on experience in a GMP-regulated environment, with direct involvement in commissioning, qualification or validation activity.
• We will consider strong candidates from adjacent roles — QC or laboratory analysts who have executed equipment qualifications, calibration and metrology technicians, manufacturing or maintenance engineers from a pharmaceutical site.
• A working understanding of IQ, OQ and PQ, and of why qualification documentation