Validation Engineer - 171296

Medix™; New Jersey; On-site; USD 80,000 - 110,000; Full time

Job summary

A leading healthcare firm is hiring a contract Validation Engineer in New Jersey. The role involves executing validation protocols for assembly and packaging equipment while partnering with cross-functional teams. Ideal candidates will have 3-8 years of experience in regulated manufacturing and hands-on validation expertise. This long-term contract offers strong growth opportunities within a dynamic environment. The position emphasizes quality systems and risk assessment management to ensure compliance.

Qualifications

• 3–8 years of validation experience in regulated manufacturing (pharma/biopharma/medical devices).
• Hands-on experience with assembly, packaging, and visual inspection equipment validation.
• Strong protocol/documentation experience in IQ/OQ/PQ.

Responsibilities

• Draft and execute validation protocols for assembly and packaging equipment.
• Define validation requirements and acceptance criteria.
• Support risk assessments and deviation management.

Skills

Validation experience in regulated manufacturing

Hands-on experience with equipment validation

Strong protocol/documentation experience

Solid understanding of quality systems

Fill-finish experience

Tools

ValGenesis

Job description

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.

Key Responsibilities

• 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).

Required Qualifications (Must-Haves)

• 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.

Preferred Qualifications (Nice-to-Haves)

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