(Senior) Validation Engineer

About ProBio:

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. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017

About the Job:

The position reports to the Sr. Validation Manager and is responsible for supporting commissioning, qualification, and validation (CQV) activities for GMP manufacturing facilities, utilities, equipment, computerized systems, and manufacturing processes. This position plays a key role in supporting multiple client programs across clinical and commercial manufacturing within a fast-paced CDMO environment.

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.

Qualifications:

• BS/MS in life science or related field with 9 years of experience in drug/biologics industry in GMP production environment in roles of validation/engineering
• Working experience in CQV for biotechnology/pharmaceutical facility is required
• Familiar with CSV in accordance to GAMP 5 and CFR Part 11
• Familiarity with process, cleaning, assay validation a plus
• Experience in aseptic fill/finish equipment qualification and aseptic process simulation (APS) is preferred
• Experience in authoring of validation protocols for utility and equipment required
• Familiar with GMP operational principles and practice
• Ability to work across functional groups for team collaboration

Pay range is estimated between $90k - $120k based on skill set and experience.

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