Junior Validation Engineer — Gene Therapy Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Parental leave

401(k) with match

Onsite fitness facility

Employee Assistance Program

Job summary

Forge Biologics in Columbus, OH is seeking a Validation Engineer I to design, implement and execute equipment validation ensuring manufacturing quality and regulatory compliance. You will collaborate across teams to develop validation strategies for Isolators, bioreactors, CTUs, and more.

Ideal candidates hold a engineering or biotech degree and have experience in regulated environments, cGMP, aseptic processing, risk assessment, and project management.

Qualifications

• Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).
• Experience in equipment validation within a regulated industry.
• Experience in qualifying a wide range of equipment including Isolators, Filling & Capping equipment, BSCs, CTUs, bioreactors, incubators, chromatography systems, and centrifuges.
• Aseptic processing and clean room standards knowledge.
• Proficiency in risk assessment methodologies.
• Strong understanding of cGMPs.

Responsibilities

• Design, implement, and execute equipment validation strategies.
• Collaborate with cross-functional teams to ensure regulatory compliance and quality.
• Provide technical expertise in equipment validation and ensure adherence to regulatory requirements.

Skills

Experience in equipment validation

Aseptic processing

Clean room standards

Risk assessment methodologies

cGMPs knowledge

Analytical/problem-solving skills

Cross-functional collaboration

Project management

Effective communication

Education

Bachelor's degree in Engineering/ Biotechnology/ Pharmaceutical Sciences

Tools

Isolators

Filling & Capping equipment

Biological Safety Cabinets

Controlled Temperature Units

Bioreactors

Incubators

Chromatography systems

Centrifuges

Job description

Forge Biologics in Columbus, OH is seeking a Validation Engineer I to design, implement and execute equipment validation ensuring manufacturing quality and regulatory compliance. You will collaborate across teams to develop validation strategies for Isolators, bioreactors, CTUs, and more.

Ideal candidates hold a engineering or biotech degree and have experience in regulated environments, cGMP, aseptic processing, risk assessment, and project management.