Validation Engineer (Downstream Biologics)

Job Description

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.

Full-time