Sr/Principal Computer Systems Validation Specialist

Job Responsibilities

• Provide oversight of enterprise software validation from a global perspective.
• Provide validation direction, guidance, review, and approval for validation lifecycle deliverables of enterprise software projects.
• Provide oversight and management to validation managed services for associated projects.
• Provide validation review and approval of enterprise software change controls, CAPAs, and deviations.
• Provide support for data integrity global initiatives.
• Provide expertise and input for global Policies, SOPs, and Templates for IT Enterprise Software

Minimum Requirements

• (Principal - BS/MS and 15+ years/ Senior - BS/MS and 8+ years) experience in a cGMP environment in a computer systems validation role with demonstrated career growth and accomplishments.
• Experience in Data Integrity, computer system validation/IT quality in an FDA regulated manufacturing environment.
• Demonstrated expert knowledge of 21CFR, Part 11, and/or EU Annex 11 as well as current regulatory guidance on Data Integrity.

Pay

• Salary Range: $118,000 - $162,800 (Senior) $133,000 - $183,700 (Principal)

Benefits

• An annual bonus structure for all employees
• Medical, dental, and vision coverage
• Paid PTO and holidays
• Sabbatical program
• 401K matching with 100% vesting in 60 days
• Employee recognition programs