As a Validations Specialist, you will develop and execute validation protocols for equipment and processes, ensuring compliance with regulatory standards. This role involves collaboration with various teams and supports continuous improvement initiatives.
Key Responsibilities
Develop, execute, and document validation protocols
Ensure compliance with FDA, GMP, and other regulatory standards
Collaborate with Quality Assurance, Manufacturing, and Engineering teams
Analyze data and prepare validation reports
Participate in audits and inspections
Support continuous improvement initiatives
Maintain accurate and organized validation records
Required Qualifications
1+ year of GMP Validations
IQ, OQ, PQ validations experience
Bio Lab experience
Validation Engineering experience
Preferred Qualifications
Six Sigma blackbelt
Qualification Engineer
Experience working with cold storage units
Benefits & Perks
Medical, dental & visionCritical Illness, Accident, and Hospital coverage401(k) Retirement PlanLife InsuranceShort and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramPTO, Vacation or Sick Leave