Validation Engineer

BioSpace; Pennington (NJ); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player in biotechnology is seeking a Validation Engineer to enhance manufacturing capabilities and support diverse client projects. This role involves executing and documenting validation activities, preparing protocols and reports, and ensuring compliance with GMP standards. The ideal candidate will have a strong background in GMP validation and CSV, contributing to the success of innovative therapies. Join a dynamic team focused on improving health through biotechnology and be part of a company committed to diversity and inclusion.

Qualifications

• Experience in GMP validation/engineering in the biologics or drug industry.
• Knowledge of GMP principles and validation protocols.

Responsibilities

• Execute and document validation activities for manufacturing.
• Review and approve validation protocols and reports.
• Supervise validation staff and coordinate with departments.

Skills

GMP validation

CSV (GAMP 5, CFR Part 11)

Validation protocols

Team collaboration

Education

BS in life sciences

MS in life sciences

Job description

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About GenScript
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group founded in 2002, with a presence across North America, Europe, Greater China, and Asia Pacific. Its businesses include gene synthesis technology, life science CRO services, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript aims to be the most reliable biotech company in the world, improving health through biotechnology.

About ProBio
ProBio offers end-to-end CDMO services from drug discovery to commercialization, focusing on cell and gene therapy, vaccines, biologics, and antibodies. They support clinical and commercial manufacturing, including plasmid and viral vector services, with a focus on mRNA vaccines and CAR-T therapies.

Job Scope: Reporting to the Validation Director/Manager, this role is ideal for a professional with experience in facility, utility, equipment, or CSV validation. It involves leading validation activities within a CDMO environment to support diverse client projects and enhance manufacturing capabilities.

Essential Responsibilities:

• Execute and document validation activities
• Review and approve validation protocols
• Prepare validation protocols and reports
• Qualify utilities and equipment
• Represent QA in validation planning and execution
• Participate in software validation
• Coordinate with departments and contractors
• Support validation programs for GMP manufacturing
• Maintain validation master plans
• Supervise validation staff

Qualifications:

• BS/MS in life sciences or related field
• Experience in GMP validation/engineering in the biologics or drug industry (Manager 9 yrs, Sr. Validation Engineer 6 yrs, Validation Engineer 3 yrs)
• Experience with CQV, CSV (GAMP 5, CFR Part 11), and validation protocols
• Knowledge of GMP principles and team collaboration skills

GenScript USA Inc./ProBio Inc. is an equal opportunity employer committed to diversity and inclusion. They maintain a drug-free workplace.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance