MF01-111925 CQV Technical Support - SME

Job Description

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.