Validation Engineer

GenScript; Pennington (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in biotechnology is seeking a Validation Engineer to lead validation functions within a CDMO. This role offers a unique opportunity to support diverse projects that enhance manufacturing capabilities. The ideal candidate will have extensive experience in the GMP biologics/drug industry, demonstrating expertise in validation protocols and a solid understanding of GMP principles. Join a forward-thinking company dedicated to making humans and nature healthier through biotechnology, and take your career to the next level in a collaborative and innovative environment.

Qualifications

• Experience in GMP biologics/drug industry with various roles.
• Knowledge of validation protocols for utilities and equipment.

Responsibilities

• Execute and document validation activities.
• Review and approve vendor validation protocols.
• Maintain validation master plans and supervise validation staff.

Skills

GMP Principles

Validation Protocols

Collaboration Skills

CSV Knowledge (GAMP 5, CFR Part 11)

CQV Experience

Education

BS in Life Sciences

MS in Life Sciences

Job description

Join to apply for the Validation Engineer role at GenScript.

About GenScript
GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the 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 is committed to becoming the most reliable biotech company in the world, making humans and nature healthier through biotechnology.

About ProBio
ProBio provides end-to-end CDMO services from drug discovery to commercialization, focusing on cell and gene therapy, vaccines, biologics, and antibody drugs. It supports clinical and commercial manufacturing, including plasmid and viral vector production, with a high-yield platform for viral vectors and GMP manufacturing for mRNA vaccines.

Job Scope
Reporting to the Validation Director/Manager, the role is suited for professionals with experience in facility, utility, equipment, or CSV validation. It offers an opportunity to lead validation functions within a CDMO, supporting diverse projects to advance manufacturing capabilities.

Essential Responsibilities

1. Execute and document validation activities.
2. Review and approve vendor validation protocols for accuracy and compliance.
3. Prepare validation protocols and reports.
4. Qualify utilities and equipment.
5. Represent QA in validation planning and execution.
6. Participate in software validation.
7. Coordinate with departments and contractors on validation activities.
8. Support validation programs for CGMP manufacturing of clinical and commercial products.
9. Maintain validation master plans and supervise validation staff.

Qualifications

1. BS/MS in life sciences or related field.
2. Experience in GMP biologics/drug industry: Manager (9+ yrs), Sr. Validation Engineer (6+ yrs), Validation Engineer (3+ yrs).
3. Experience in CQV for biotech/pharma facilities.
4. Knowledge of CSV (GAMP 5, CFR Part 11).
5. Experience in validation protocols for utilities and equipment.
6. Understanding of GMP principles.
7. Ability to collaborate across teams.

GenScript USA Inc./ProBio Inc. is an equal opportunity employer committed to diversity and inclusion. We maintain a drug-free workplace. Only verified application sources will be used for contact.