Aseptic Validation Engineer (Pharma)

Description:

Lead CQV activities for analytical instrumentation and automated manufacturing equipment (URS, IQ, OQ, PQ).

Handle sterilization process qualifications, APS, and process validation per cGMP/USP/SOPs.

Perform automation assessments (21 CFR Part 11) and author validation documentation (APS, PPQ, material qualifications).

Collaborate with cross-functional teams (QA, QC, IS, EH&S, vendors) to ensure compliance with ISO, GAMP, ANSI standards.

Bring 5–8 years CQV experience, engineering degree (or equivalent), with strong GMP/lab background, troubleshooting

Job Type: Contract

Pay: $60.00 - $80.00 per hour

Expected hours: 40 per week

Benefits:

- Health insurance

- Vision insurance

Experience:

- CGMP: 5 years (Required)

- Analytical Instrumentation and Manufacturing equipment: 5 years (Required)

- sterilization process / ASEPTIC PROCESS: 5 years (Required)

Work Location: On the road