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Validation Engineer - Join Our Expert Team

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Bachelor’s degree in Engineering, Life Sciences, or a related field. A minimum of 5 years of validation experience in the pharmaceutical, biotechnology, or similarly regulated industries. Practical experience in validating manufacturing equipment, laboratory instruments, and/or computerized systems. In-depth understanding of GMP, GLP, and relevant regulatory guidelines. Exceptional analytical, organizational, and technical writing capabilities. Proven ability to work independently as well as collaboratively in cross-functional teams. Preferred Skills:Experience in cleaning validation, sterilization, utilities (HVAC, water, compressed gases). Familiarity with data integrity and 21 CFR Part 11 compliance. Understanding of risk-based validation methodologies (e.g., ASTM E2500).

About the job

We are on the lookout for a dedicated and enthusiastic Validation Engineer to contribute to our validation efforts in regulated sectors such as Pharmaceuticals, Biotechnology, Medical Devices, Chemicals, and Food Manufacturing. The Validation Engineer's primary role will be to ensure that our equipment, systems, and processes comply with regulatory standards, thereby safeguarding product quality and patient safety.

Key Responsibilities:

  • Design, develop, and implement validation protocols (IQ, OQ, PQ) for machinery, utilities, facilities, and production systems.
  • Facilitate the validation of laboratory instruments, manufacturing equipment, cleaning procedures, and computerized systems.
  • Ensure adherence to cGMP, FDA, EMA, and other relevant regulatory guidelines.
  • Prepare and evaluate validation documentation, including protocols, reports, SOPs, and risk assessments.
  • Conduct troubleshooting and root cause analysis for any validation or equipment-related discrepancies.
  • Collaborate with multidisciplinary teams (Engineering, Quality, Manufacturing, Laboratory) to achieve project goals.
  • Engage in change control, CAPA, and continuous improvement projects.
  • Maintain precise records and ensure that documentation remains audit-ready at all times.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Inc. (V&EG) is a premier service provider delivering tailored solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our expertise spans several domains, including Laboratory, Compliance, Computer Engineering, Project Management, Validation, and beyond.

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