Validation Scientists (Facilities & Utilities)

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:

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.

Full-time