MV01-122325 Validation Engineer (Downstream Biologics)

Validation & Engineering Group, Inc. (V&EG) 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 ideal 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.