Equipment Validation Specialist

Zoetis • Lincoln, NE

4d • Onsite

About The Position

The Equipment Validation Specialist is a new role that will be primarily focused on equipment validation periodic reviews and report to the Validation Program Manager. Periodic review plays a critical role in the validation lifecycle, serving as the bridge between initial equipment qualification and ongoing compliance assurance. The successful candidate will perform comprehensive equipment assessments, analyze equipment performance data, write periodic review summary reports, and manage the periodic review scheduling.

Requirements

• 2-year degree/certificate in an engineering or science-based field
• 5 Years of experience working in a cGMP / regulated environment
• Strong technical writing ability
• Verbal and written communication skills (fluent in English)
• Functional knowledge of internal and external requirements associated with equipment validation.
• Demonstrated ability to establish appropriate timelines to meet key milestones with minimal supervision.
• Investigation and Problem Solving Ability to analyze data and draw scientific conclusions.
• Work effectively in a cross-functional and team-based environment.

Nice To Haves

• 4-year degree/certificate in an engineering or science-based field
• Project management / leadership experience
• Six Sigma Green Belt certification
• Demonstrated ability to escalate issues.

Responsibilities

• Periodic review equipment performance against validated state
• Physical evaluation of equipment to verify operational conditions, including visual inspection and occasional surface sampling for laboratory analysis
• Author equipment validation periodic review reports
• Manage the equipment schedule for periodic review.
• Initiate investigations upon discovery of validation discrepancies.
• Support regulatory agency, customer, and internal audits.
• Maintain cGMP compliance with department Standard Operating Procedures (SOPs), Zoetis Quality Standards and 21CFR, EU and other regulatory guidelines.
• Review and approval of ETS action items / commitment tracking items
• Perform documentation review.
• Participate in change management activities.
• Other responsibilities as assigned.

Benefits

• $500 Sign on Bonus
• 4 weeks accrued paid vacation and 13 paid holidays.
• 401(k) match with company profit sharing.
• Tuition reimbursement and Student Loan repayment program.
• Great Health, personal, and family benefits starting day 1.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree