Validation Engineer

Job Description

Job Summary

We are seeking a skilled Validation Engineer to support validation activities across manufacturing, utilities, equipment, and computerized systems in a regulated pharmaceutical environment. The ideal candidate will ensure compliance with FDA, cGMP, and global regulatory standards.

Key Responsibilities

• Plan and execute IQ, OQ, and PQ for equipment, facilities, utilities, and systems
• Develop, review, and approve validation protocols and reports
• Perform process, cleaning, and computer system validation (CSV)
• Ensure compliance with FDA 21 CFR Part 11, cGMP, GAMP 5
• Support audits, inspections, deviations, CAPAs, and change controls
• Collaborate with Manufacturing, Quality, Engineering, and IT teams
• Maintain validation documentation and lifecycle management

Required Qualifications

• Bachelor’s degree in Engineering, Pharmacy, or Life Sciences
• 2-4 years of validation experience in the pharmaceutical or biotech industry
• Strong knowledge of GMP regulations and validation lifecycle
• Hands-on experience with IQ/OQ/PQ, CSV, and process validation
• Excellent documentation and communication skills

Thanks

Suchi

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.

Vastek Inc is managed by a group of dedicated professionals having rich experience of over years in Healthcare, IT consulting and staffing. We are a certified minority owned, Small business company head quartered out of San Diego, with coverage all across United States, Canada, Mexico, Italy and India. We specialize in Engineering, Validation, Regulatory, IT and NON-IT related areas primarily focused on Pharmaceutical / Life Sciences and Medical device companies.