Lc01 042525 Environmental Monitoring Performance Qualification (empq) Scientist
Humacao, PR, US, United States
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:
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.
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Job Detail
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Job IdJD5823410
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationHumacao, PR, US, United States
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EducationNot mentioned