Sr. Validation Engineer 1 - Eurofins

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 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 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

• Applies GMP/GLP in all areas of responsibility, as appropriate
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Applies the highest quality standard in all areas of responsibility
• 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 complianceregulations, and requirements. Ensure projects are completed in compliance with existing qualitysystems; Utilize independent judgement and experience to make quality based decisions.
• Provide support to implement new quality systems and programs. Provide support and input forclient 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 intoexisting data center environments and workflows.
• Technical Writing - Author validation deliverables in accordance with established validationprogram. Develop and enhance software/instrumentation procedures.
• Training - Provide guidance and coaching within a team environment. Provide training totechnical groups. Assist with developing training program and procedures.
• Validation Support - Accurately update validation program components. Perform evaluation ofperiodic review data for computerized systems. Provide oversight and/or perform e-recordevaluations/remediation and provide guidance to technical groups
• Validation Testing - Assist with determining the approach to validate software andinstrumentation. Utilize risk-based rationale to support approach. Provide quality projectoversight and guidance to assist technical with testing. Review testing documentation generatedby vendors, technical groups, and/or other validation team members. Summarize results andmaintain documentation in an organized GXP compliant manner to demonstrate status.
• Conducts all activities in a safe and efficient manner
• Communicates effectively with client staff members • Performs other duties as assigned

Qualifications

• Bachelors degree in physical science, engineering, or information technology

• 5 years of laboratory software and/or analytical instrumentation research,installation, programming, networking, and/or validation. Experience mustinclude 2 years of authoring instrument validation deliverables (e.g.protocols, test scripts) within a GXP environment, Acombination of college and related technical experience will be considered(e.g. 9+ years' experience)

• Strong knowledge of Windows OS, networking, and instrument PCconnectivity and configuration (securities and file structure

• 5 years of experience with ELLI internal quality systems and procedures Quality/regulatory experience preferred

Additional Information

This position is full time Monday-Friday 9:00 am-5:00pm with over