LC01-042525 Environmental Monitoring Performance Qualification (EMPQ) Scientist

Job DescriptionJob 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:

• Environmental Monitoring Performance Qualification (EMPQ) - Sr CQV Scientist

  • Evaluate project change control and confirm EM PQ scope of work.

  • Generate Validation Plan (VP).

  • Develop and execute EM PQ protocols.

  • Develop EM PQ reports for applicable systems.

  • Pursue project deliverables.

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.
• Solid experience performing Environmental Monitoring Performance Qualification (EMPQ).
  • Sampling Plan strategy and data analysis of results
• Experience with Commissioning, Qualification and Validation (CQV).
• Solid experience in the development of Risk Assessments.
• Practical knowledge developing and executing Computer System Life Cycle (SDLC) documents. i.e. VP, URS, FDS, RA, IOPQ, TMX, and Reports.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.