(Sr.) Validation Engineer

About GenScript

Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products. Guided by its mission to Make People and Nature Healthier Through Biotechnology, and its role as a well-recognized biotechnology company, GenScript has a team of approximately 6,165 employees and has served more than 200,000 customers across over 100 countries and regions.

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 $80k - $120k based on skill set and experience.

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Benefits:

Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.