Validation & Engineering Group, Inc. (V⪚) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Engineer
Project Duration: 4–6 months, with potential for extension or future projects at the site.
Role Summary:
We are seeking a self-sufficient Validation Engineer to support a downstream biologics validation project at a cGMP manufacturing site in Puerto Rico. The idóneo candidate has hands‑on experience validating downstream processes, equipment, and instruments and can manage validation activities with minimal supervision.
Key Responsibilities:
- Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support).
- Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF‑DF, centrifuges, formulation systems, and lyophilizers.
- Validate analytical and process instruments (e.G., HPLC, in‑line sensors).
- Author and execute validation protocols and reports in compliance with cGMP/FDA requirements.
- Collaborate with Engineering, Manufacturing, Quality, and Automation teams.
- Support deviations, change controls, and audit readiness as needed.
Required Experience:
- Bachelor’s degree in Engineering or Life Sciences.
- 5+ years validation experience in biologics/pharmaceutical manufacturing.
- Strong hands‑on experience with downstream process and equipment validation.
- Ability to work on‑site and operate independently.
- Excellent documentation and communication skills.
Preferred:
- Prior support of commercial manufacturing or PPQ.
- Availability for project start within short notice.
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