MF01-111124 QA Lab Equipment Qualification Specialist

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:

• QA Lab Equipment Qualification Specialist
  • Help document the necessary specifications for the equipment to purchase.
  • Basic knowledge of laboratory equipment and its use.
  • Basic knowledge of document control systems (such as Cdocs or Veeva Vault).
  • Write design documents, including Qualification Plans and Design Qualification Reports.
  • Write and execute qualification documents, such as Installation and Operational Qualification and Performance Qualification.
  • Write and execute equipment decommissioning documents

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Strong knowledge in cGxP and regulatory guidance and compliance.
• Experience in the development of SDLC Documentation Risk Assessment, URS, VP, DS, TMX, IQ, OQ, PQ protocols development and execution, deviations and reports generation.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.