Packaging & Assembly Equipment Qualification Specialist

Position: Packaging & Assembly Equipment Qualification Specialist Location: East Greenbush, NY Duration: 12+ months contract (W2)

Experience: 5 - 7 Years Work Authorization: Must have valid US work authorization

About the Role

We’re looking for a Packaging & Assembly Equipment Qualification Specialist with hands-on experience in equipment qualification, validation documentation, and aseptic operations. You’ll be supporting packaging line and auto-injector assembly operations in a GMP-regulated environment.

Key Responsibilities

Develop and execute EQA, IQ, and OQ protocols for packaging and serialization systems (cartoners, case packers, palletizers, auto-injector assembly equipment).

Conduct Area Clearance Assessments (ACA) to ensure equipment readiness and compliance.

Author qualification documents based on URS and EQA.

Draft and execute traceability matrices; perform OPQ runs on filling lines.

Review Software Life Cycle documentation (HDS, SDS, I/O Lists, Alarm Lists, Set-point Lists, Recipe Lists).

Assist in drafting recipes and set points for automated assembly machines.

Verify calibration and maintenance plans in the BMRAM system.

Conduct Data Integrity and FMEA Risk Assessments; address high/moderate risk items in protocols.

Maintain strong aseptic gowning skills and adhere to cleanroom behavior protocols.

Skills & Experience

• Proven experience in equipment qualification within a GMP environment.

• Strong knowledge of validation documentation and regulatory compliance.

• Familiarity with packaging and serialization systems.

• Hands-on aseptic gowning and cleanroom behavior.

• Ability to interpret and author technical documentation.