Validation Specialist

2 days ago


Foster City, California, United States ACL Digital Full time
Job Title: Validation Engineer

ACL Digital is seeking a skilled Validation Engineer to join our team.

About the Role

We are looking for a highly motivated and experienced Validation Engineer to support the qualification of Analytical Laboratory Instrumentation. The ideal candidate will have a strong background in validation and qualification of computerized analytical instruments, with a focus on software compliance and data integrity.

Key Responsibilities
  • Assess instrument software for compliance with 21 CFR Part 11, Annex 11, and data integrity requirements.
  • Develop validation deliverables in collaboration with cross-functional teams.
  • Execute protocols and develop validation summary reports.
  • Review vendor-executed protocols to ensure instrument qualification meets intended use.
  • Ensure instrument systems are validated per their intended use and meet data integrity and data security requirements.
  • Assess, author, implement, and close change management requests related to qualification, relocation, requalification, upgrade, and decommissioning.
  • Prepare regulatory submissions and present validation documentation to regulatory authorities.
Requirements
  • Bachelor's degree in a relevant field.
  • 5+ years of experience in a relevant or related field.
  • Experience with Pharmaceutical/Biotechnology clients is strongly recommended.
  • Strong team player with excellent communication and problem-solving skills.
What We Offer

ACL Digital offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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