Computer System Validation Engineer
Company: Eurofins USA
Location: Saint Charles
Posted on: May 14, 2022
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
- 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
- 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
- Participates in periodic equipment assessment activities to
evaluate software application requirements.
- Participates in instrument selection, software application
evaluation, acquisition, implementation, and performance monitoring
- Prepares and/or reviews all computer system validation plans
- 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
- 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
- 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
- Organizational skills to manage multiple priorities.
- Ability to read and interpret documents such as safety rules,
standard operating procedures, maintenance instructions, and
- 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
- 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
Keywords: Eurofins USA, Saint Charles , Computer System Validation Engineer, IT / Software / Systems , Saint Charles, Missouri
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