Validation Specialist

5 days ago


Columbia, Missouri, United States Eurofins USA BioPharma Services Full time
Job Description

Eurofins USA BioPharma Services is seeking a highly skilled Validation Specialist to join our Quality Systems team in Columbia, Missouri. The successful candidate will be responsible for ensuring the compliance of computer systems with US FDA regulations and Eurofins corporate policies and procedures.

Key Responsibilities:
  • Develop and implement validation plans, risk assessments, and validation protocols for computer systems.
  • Author and execute validation documents, including validation plans, GxP assessments, traceability matrices, and validation summary reports.
  • Maintain awareness of data management, validation, and data integrity needs in a GxP regulated environment.
  • Stay up-to-date with regulatory requirements and industry standards related to computer systems used in the manufacture and testing of pharmaceutical products.
  • Collaborate with cross-functional teams to ensure compliance with quality systems and regulatory requirements.
Requirements:
  • Bachelor's degree in Computer Science or a related field.
  • Minimum 2+ years of experience in GMP document creation related to CSV.
  • Knowledge of cGMP, GDP, GAMP, 21CFR 210, 211, 58, and Part 11.
  • Understanding of principles of data integrity and the relationship to regulatory requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.

Eurofins USA BioPharma Services is an equal opportunity employer and welcomes applications from diverse candidates. If you are a motivated and detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.


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