Lc01-042525 Environmental Monitoring Performance Qualification (Empq) Scientist

Validation & Engineering Group

Humacao, PR
Permanente
Tiempo completo

Hace 5 días

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 ScientistEvaluate 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.

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