Validation Engineer

Role:
Qualification & Validation Engineer

Job Description:

We are seeking an experienced Qualification & Validation Engineer to support CQV, equipment qualification, commissioning, and validation activities within a GMP-regulated pharmaceutical or biotechnology environment.

• Execute FAT, SAT, IQ, OQ, PQ, commissioning, requalification, and periodic assessment activities.
• Author, execute, review, and approve protocols, reports, RTMs, and validation documentation.
• Support manufacturing, laboratory, facility, utility, cleanroom, and process equipment qualification.
• Manage Change Controls, Deviations, CAPAs, risk assessments, and technical investigations.
• Support commissioning and qualification for new equipment, capital projects, facility expansions, and startup activities.
• Collaborate with Engineering, Manufacturing, QC, QA, Facilities, and Materials teams.
• Provide technical support for troubleshooting, audit readiness, and regulatory inspections.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 5+ years of Qualification, Validation, CQV, or Commissioning experience in pharmaceutical, biotechnology, or medical device industries.
• Strong knowledge of FDA, cGMP, GAMP 5, ICH guidelines, and GMP documentation practices.
• Experience with eQMS systems such as Track Wise, Veeva, or Master Control is preferred.
• Experience in biologics, cell & gene therapy, vaccines, or sterile manufacturing is a plus.