Validation Engineer

  • Full-time

Company Description

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.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Job Summary: Eurofins Quality Engineering is looking for a Senior Validation Engineer responsible for authoring validation deliverables in accordance with established procedures and independently coordinating validation projects for routine (duplicate/similar) laboratory instrumentation and software. This individual will also assist with research and coordination of complex/unique (new) laboratory instrumentation and software, ensuring integration with existing data center environments and workflows as well as provide oversight, guidance, and training to technical personnel.

Job Duties:

  • Apply GLP/GMP in all areas of responsibility, as appropriate
  • Demonstrates and promotes the company vision
  • Demonstrates strong client service skills, teamwork, and collaboration
  • Proactively plans and multitasks to maximize productivity
  • Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration
  • Compliance - Stay current with client, regulatory, validation, IT, and e-record compliance regulations, and requirements. Ensure projects are completed in compliance with existing quality systems; Utilize independent judgement and experience to make quality based decisions. Provide support to implement new quality systems and programs. Provide support and input for client and/or regulatory audits
  • Research - Assist with research of instrumentation with information obtained from vendors, manuals, and other resources to introduce new instruments. Integrate instrumentation into existing data center environments and workflows.
  • Technical Writing - Author validation deliverables in accordance with established validation program. Develop and enhance software/instrumentation procedures.
  • Training - Provide guidance and coaching within a team environment. Provide training to technical groups. Assist with developing training program and procedures.
  • Validation Support - Accurately update validation program components. Perform evaluation of periodic review data for computerized systems. Provide oversight and/or perform e-record evaluations/remediation and provide guidance to technical groups
  • Validation Testing - Assist with determining the approach to validate software and instrumentation. Utilize risk-based rationale to support approach. Provide quality project oversight and guidance to assist technical with testing. Review testing documentation generated by vendors, technical groups, and/or other validation team members. Summarize results and maintain documentation in an organized GXP compliant manner to demonstrate status.

Qualifications

Minimum Qualifications:

  • Bachelors degree in physical science, engineering, or information technology
  • 3-5 years of laboratory software and/or analytical instrumentation research, installation, programming, networking, and/or validation. Experience must include 2 years of authoring instrument validation deliverables (e.g. protocols, test scripts) within a GXP environment. A combination of college and related technical experience will be considered (e.g. 9+ years experience)
  • Strong knowledge of Windows OS, networking, and instrument PC connectivity and configuration (securities and file structure)

Additional Information

Position is full-time position, Monday - Friday 8:00pm - 5:00pm. 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

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

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