Sr. Validation Engineer

ProBio•Pennington, NJ

1d•$80,000 - $120,000

About The Position

ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery through GMP for plasmids, antibodies, and cell and gene therapies. The company has operations in the United States, the Netherlands, South Korea, and China, serving customers worldwide. Since October 2017, ProBio has helped customers obtain more than 150 IND approvals. The Sr. Validation Engineer reports to the Associate Director of Validation and supports commissioning, qualification, and validation (CQV) activities for GMP manufacturing facilities, utilities, equipment, computerized systems, and manufacturing processes. The role supports multiple client programs for clinical and commercial manufacturing in a fast-paced CDMO environment. The engineer prepares and executes validation protocols and reports, supports technology transfers and manufacturing startups, and coordinates with cross-functional teams and external vendors. The position also supports quality investigations, audits, regulatory inspections, and continuous improvement efforts. The estimated pay range is $80,000–$120,000, based on skill set and experience. Benefits include medical, dental, and vision insurance; a 401(k) plan with company match that vests fully on day one; paid parental leave after three months; paid time off; flexible spending and health savings accounts; life and AD&D insurance; short- and long-term disability coverage; legal assistance; supplemental insurance plans; commuter benefits; well-being initiatives; and peer-to-peer recognition programs. ProBio Inc. is an equal opportunity/affirmative action employer committed to a diverse and inclusive workforce and maintains a drug-free workplace.

Requirements

BS or MS in life science or a related field.
At least 4 years of experience in the drug or biologics industry in a GMP production environment, in validation or engineering roles.
Working experience in CQV for a biotechnology or pharmaceutical facility.
Familiarity with CSV in accordance with GAMP 5 and 21 CFR Part 11.
Experience authoring validation protocols for utilities and equipment.
Familiarity with GMP operational principles and practices.
Ability to collaborate across functional groups.

Nice To Haves

Additional industry experience beyond the stated minimum is preferred.
Familiarity with process, cleaning, or assay validation.
Experience with aseptic fill/finish equipment qualification and aseptic process simulation (APS).

Responsibilities

Execute CQV activities for facilities, utilities, process equipment, and manufacturing systems.
Develop, review, and execute IQ, OQ, and 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 meeting project timelines and quality requirements.

Benefits

Medical, dental, and vision insurance.
401(k) retirement plan with company match that vests fully on day one.
Paid parental leave after three months of employment.
Paid time off including vacation, personal time, sick time, floating holidays, and company holidays.
Flexible spending and health savings accounts.
Life and AD&D insurance.
Short- and long-term disability coverage.
Legal assistance.
Supplemental pet, critical illness, accident, and hospital indemnity insurance plans.
Commuter benefits.
Well-being initiatives.
Peer-to-peer recognition programs.