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.