Equipment Validation Scientist

West Point, PA, USA Full-time

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Employee Responsibilities:

• Partnering with laboratory end users, quality support, lab computing, and instrument vendors to lead specific computerized systems validation activities (analytical instrumentation in a large molecule laboratory setting)
• Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in BVA laboratories.
• Initiates and leads risk assessment, gap analysis, and deviation management associated with the installation, qualification, and validation of various laboratory instruments.
• Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument. Previous experience with PR/CAPA systems preferred.
• Able to understand and follow procedures
• Participate in regulatory agency and internal audits
• All other duties as assigned

The Ideal Candidate would possess:

• Familiarity with system validations and associated regulations (21 CFR Part 11 Compliance)
• Hands on experience operating computerized instrument systems.
• Demonstrated attention to detail.
• Must be able to work independently.
• Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.).
• Familiarity with enterprise systems such as but not limited to Empower, Labware LIMS, Expressionist, and LINK.
• Demonstrated ability to work in a team environment and manage workload to meet deadlines.
• Excellent communication skills both oral and written
• Strong organization and attention to detail
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies (GMP knowledge a plus)
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Bachelor’s degree in a science or engineering related discipline with knowledge in quality operations laboratory processes.

At least 4 years of experience in the validation of analytical laboratory systems, preferably in the Pharmaceutical industry.

Authorization to work in the United States indefinitely without restriction or sponsorship

Position is full-time, Monday - Friday 8:00am - 5:00pm. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.