Lancaster, Pennsylvania, USA
25 days ago
Sr. Validation Engineer 1

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 DescriptionApplies GMP/GLP in all areas of responsibility, as appropriateDemonstrates and promotes the company visionRegular attendance and punctualityApplies the highest quality standard in all areas of responsibilityDemonstrates strong client service skills, teamwork, and collaborationProactively plans and multitasks to maximize productivityMeets all quality and productivity metrics and demonstrates strong teamwork and collaborationCompliance - 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 auditsResearch - 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.Conducts all activities in a safe and efficient mannerCommunicates effectively with client staff members  Performs other duties as assigned

QualificationsBachelors 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 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 structure5 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 overtime as needed. 

Candidates currently living within a commutable distance of Lancaster Pennsylvania are encouraged to apply.

As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.

 

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

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