Lab Instrument System Validation Administrator - Eurofins USA BioPharma Services

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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

In 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

• Subject Matter Expert (SME) - Maintain instrument/software in a validated state at all times. Perform assessment, trouble-shooting, repair. Develop and implement CAPA to resolve issues as needed. Ensure completion of preventative maintenance and routine qualification testing. Install, configure software for electronic record compliance. Perform testing to identify gaps and develop remediation as required. Routinely analyze system logs/audit trails, perform software/firmware upgrades, update user account information, and complete periodic system compliance reviews.
• Validation Testing - Determine and/or assist with determining the approach to test and validate instrumentation. Provide technical and risk-based rationale to support approach. Coordinate installation and/or execute testing (as required).
• Review testing documentation generated by vendors and/or other team members. Compile and maintain documentation in an organized GXP compliant manner to demonstrate status.
• Applies GMP/GLP in all areas of responsibility, as appropriate
• Compliance - Ensure projects are completed in compliance with existing quality systems. Stay current with client, regulatory, validation, IT, and e-record regulations and requirements. Assist with implementing new internal practices and procedures.
• Research - Research and on-board new instrumentation; Assist with integration of instrumentation into existing data center environments and workflows
• Technical Writing - Provide technical input for validation deliverables, investigations, and develop/enhance procedures in accordance with established quality programs
• Training - Provide training to system users and other admins; Assist with developing training program and procedures
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned

The Ideal Candidate would possess:

• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Experience in the analysis of therapeutic proteins using various HPLC Techniques including IEX, SEC, HIC and RP and CE including ICE and CE.
• Excellent oral and written communication skills
• The candidate must have effective documentation skills with the ability to author internal technical reports
• Experience with Microsoft Word and Excel is required

Minimum Qualifications:

• Bachelor's in physical science (chemistry, engineering, computer science, etc.). Additional years of directly-related experience may be considered in lieu of degree (two years of directly related industry experience is equivalent to one full-time year of college in related major)

Position is full-time, Monday - Friday, 8am - 5pm.  Candidates currently living within a commutable distance of Lancaster, 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.