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:

• Bachelor’s 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.

  • cGMP regulations (21 CFR Part 210/211)

  • FDA, EMA, and WHO guidelines

  • ISPE Baseline Guide Vol. 4: Water and Steam Systems

  • GAMP 5 (for computerized control systems)

  • Ability to ensure systems meet Data Integrity and Audit Trail requirements.

• 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.