Validation Engineer

We are hiring a contract Validation Engineers to support Fill-Finish on the Finished Goods side
, focused on assembly qualification and packaging qualification
. This role is hands‑on and will partner with Manufacturing, Engineering, QA/QC, and Automation to draft and execute IQ/OQ/PQ protocols
, troubleshoot equipment issues during qualification, and support quality system activities (deviations, change controls, risk assessments, investigations). This is a long‑term contract on a growing team with strong learning and development opportunity.

• Draft and execute validation protocols including IQ, OQ, and PQ for assembly and packaging equipment supporting finished goods operations.
• Define validation requirements, acceptance criteria, and testing strategy
• Execute testing in the field, document results, and write final reports
• Support risk assessments
  , including identifying critical parameters and linking them to qualification testing.
• Manage or support deviations, investigations, and CAPAs tied to qualification execution—understanding root cause (“the why”) and helping prevent repeat issues.
• Support change control activities related to equipment, processes, documents, and qualification packages.
• Provide technical troubleshooting of assembly/packaging equipment during commissioning and PQ execution, working directly with cross‑functional teams.
• Review and verify technical documentation (manuals, drawings, vendor docs, calibration/PM records) to support qualification packages.
• Collaborate with Manufacturing/Engineering/Automation when alignment is needed (including resolving disagreements on approach, requirements, and test coverage).

• 3–8 years of validation experience in regulated manufacturing (pharma/biopharma/medical devices).
• Hands‑on experience with equipment validation/qualification on one or more of the following:
• Assembly equipment
• Packaging equipment
• Visual inspection equipment (either manual inspection processes or automated systems)
• Strong protocol/documentation experience (writing and executing IQ/OQ/PQ
  , and supporting validation reports).
• Solid understanding of quality systems
  : risk assessments, deviations, investigations, change controls
  .
• Fill-finish experience strongly preferred
  , specifically on the Finished Goods side.

• Experience validating automated visual inspection systems
  , vision systems
  , and/or automation
  .
• Familiarity with Val Genesis (or similar validation lifecycle tools).
• Experience performing or supporting 21 CFR Part 11 assessments
  .
• Background in commissioning + qualification workflows and off‑shift PQ execution.