Validation Engineer

Responsibilities

• Execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, process equipment, and manufacturing systems
• Develop, review, and execute IQ, OQ, PQ protocols and validation reports
• Support facility, utility, equipment, process, cleaning, and computer system validation (CSV) activities
• Support technology transfer and startup activities for new client manufacturing programs
• Prepare validation documentation in accordance with cGMP, FDA, EU GMP, GAMP 5, and 21 CFR Part 11 requirements
• Support deviation investigations, CAPAs, change controls, and risk assessments related to validation activities
• Coordinate validation activities with Manufacturing, Engineering, QA, QC, Automation, and external vendors
• Participate in FAT, SAT, commissioning, equipment qualification, and facility expansion projects
• Maintain validation documentation and ensure data integrity throughout the validation lifecycle
• Support client audits, regulatory inspections, and internal quality audits
• Identify opportunities for continuous improvement of validation processes and engineering systems
• Support multiple client projects simultaneously while ensuring project timelines and quality requirements are achieved

Requirements

• BS/MS in life science or related field
• 9 years of experience in drug/biologics industry in GMP production environment
• Experience in validation or engineering roles
• Working experience in CQV for biotechnology/pharmaceutical facility
• Familiarity with CSV in accordance to GAMP 5 and CFR Part 11
• Experience in authoring validation protocols for utility and equipment
• Familiarity with GMP operational principles and practice

Preferred Qualifications

• Familiarity with process, cleaning, and assay validation
• Experience in aseptic fill/finish equipment qualification and aseptic process simulation (APS)

Benefits

• Medical, dental, and vision insurance
• 401(k) retirement plan with company match
• Paid parental leave
• Paid time off (vacation, personal, sick, floating holidays)
• Health savings accounts and flexible spending accounts
• Life and AD&D insurance
• Short- and long-term disability coverage
• Commuter benefits

About the Company

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies.