CQV Technical Support - SME

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:

CQV Technical Support - SME

Evaluate current manufacturing process control strategy. Develop qualification/validation strategy.

Serve as SME to develop and execute qualification packages.

Revise and approve qualification documents.

Develop sampling plan to be executed during equipment qualification/validation activities.

Lead/Facilitate Quality Risk Assessment (RA)

Lead and/or participate on triage activities.

Own change controls supporting the projects.

Review and revise manufacturing instructions and SOPs as applicable to start-up of new equipment

Qualifications:

Bachelor's Degree in Science or Engineering.

Minimum of 7 years of experience in direct pharmaceutical, medical device or biotechnology industries.

Experience in direct process / manufacturing areas.

Must be fully bilingual (English / Spanish) with excellent oral skills.

SME in the Computer System Development Life Cycle (SDLC)

Technical Writing skills and investigations processes.

Available to work extended hours, possibility of weekends and holidays.

Full-time