What are the responsibilities and job description for the MF01-060925 Validation Scientists (Facilities & Utilities) position at Validation & Engineering Group?
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:
- Qualification Scientists for USP Water Generation and Distribution System
Qualifications:
- Bachelors degree in Engineering, Life Sciences, or a related technical field (e.g., Chemical Engineering, Mechanical Engineering, Biotechnology, or Pharmaceutical Sciences).
- Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Thorough understanding of USP requirements (especially <1231>, <643>, <645>, <1051>) for pharmaceutical water systems.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
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cGMP regulations (21 CFR Part 210/211)
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FDA, EMA, and WHO guidelines
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ISPE Baseline Guide Vol. 4: Water and Steam Systems
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GAMP 5 (for computerized control systems)
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Ability to ensure systems meet Data Integrity and Audit Trail requirements.
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- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.