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Computer System Validation Engineer

Company: Eurofins USA
Location: Saint Charles
Posted on: May 14, 2022

Job 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 DescriptionThe CSV Engineer will work in close cooperation with the Director of Operations, EPBS Management, and the Quality Assurance Unit to forecast, plan, develop, execute, and document computer system validations validating the functionality and interface of laboratory equipment/instruments with their respective software applications meets the requirements of EPBS laboratory operations throughout the lifecycle of the system.Essential Duties and Responsibilities:

  • Responsible for forecasting, planning, developing, executing, and documenting computer system validations (including change controls) in accordance with 21 CFR Part 11, GDPR, and Annex 11 guidelines.
  • Responsible for performing/overseeing that the required computer system maintenance is completed per the facility's Standard Operating Procedures (SOP's).
  • Engage business/operations stakeholders to gather user requirement and functional specifications to build computer system validation documents
  • Participates in periodic equipment assessment activities to evaluate software application requirements.
  • Participates in instrument selection, software application evaluation, acquisition, implementation, and performance monitoring as assigned.
  • Prepares and/or reviews all computer system validation plans and reports.
  • Sets up laboratory computer system as required for testing GxP or CLIA samples or research samples.
  • Responsible for purchasing and maintaining current service contracts for applicable computer systems
  • Provides training on computer systems to those required.
  • Reviews and updates computer system SOP's and as needed.
  • Demonstrates and promotes the company vision
  • Regular attendance and punctuality
  • Applies GxP in all areas of responsibility, as appropriate
  • Conducts all activities in a safe and efficient manner
  • Performs other duties as assigned
  • Provides cross-functional support to other departments as required
  • Adjusts work hours as needed to meet client deadlines
  • Adheres to site employee health and safety (EHS) requirementsQualificationsTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
    • Bachelor's Degree in information technology, science, or engineering related field from a four-year college or university.
    • Greater than three (3) years related experience in laboratory IT, operations, or computer system validation.
    • Or equivalent combination of education and experience.
    • Ability to work effectively as a member of a team and lead a team.
    • Organizational skills to manage multiple priorities.
    • Ability to read and interpret documents such as safety rules, standard operating procedures, maintenance instructions, and procedure manuals.
    • Ability to write reports and correspondence.
    • Ability to effectively communicate orally and in writing to coworkers, supervisor, and clients.
    • Proficient in Excel and Word.
    • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited information is available.
    • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
    • Have a positive attitude
    • Ability to work in a laboratory setting, meeting the physical requirements.Additional InformationAll your information will be kept confidential according to EEO guidelines.Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Keywords: Eurofins USA, Saint Charles , Computer System Validation Engineer, IT / Software / Systems , Saint Charles, Missouri

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