Entry-Level Validation Engineer for Biologics Manufacturing

Forge Biologics; Columbus (OH); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Parental leave

401(k) with match

Onsite gym

Employee assistance program

Free snacks

Job summary

Forge Biologics in Columbus, OH is seeking a Validation Engineer I to design, implement, and execute equipment validation activities ensuring compliant manufacturing processes. You will work with cross-functional teams to develop validation strategies and provide technical expertise in equipment validation.

Qualified candidates have experience in regulated validation, aseptic processing, and cGMPs, with strong problem-solving, communication, and project management skills for multiple concurrent

Qualifications

• Bachelor's degree in Engineering, Biotechnology or related field.
• Experience in equipment validation within a regulated industry.
• Experience qualifying Isolators, Filling & Capping equipment, BSCs, CTUs, bioreactors, incubators, chromatography systems and centrifuges.
• Understanding of aseptic processing and clean room standards.
• Proficiency in risk assessment methodologies.
• Understanding of cGMPs (current Good Manufacturing Practices).
• Excellent analytical, problem-solving, and decision-making skills with meticulous attention to detail.
• Effective communication and collaboration across cross-functional teams.
• Strong project management skills to handle multiple validation projects concurrently.
• Ability to work in a cleanroom with gowning and PPE up to 50% of time.

Responsibilities

• Design, implement, and execute equipment validation activities.
• Develop validation strategies and provide technical expertise.
• Ensure compliance with regulatory requirements across manufacturing processes.

Skills

Equipment validation

Aseptic processing

Risk assessment

cGMPs

Analytical thinking

Problem solving

Project management

Cross-functional teamwork

Attention to detail

PPE in cleanroom

Education

Bachelor's degree in Engineering/ Biotechnology/ Pharmaceutical Sciences or related

Tools

Isolators

Filling & Capping

Biological Safety Cabinets

CTUs

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 activities ensuring compliant manufacturing processes. You will work with cross-functional teams to develop validation strategies and provide technical expertise in equipment validation.

Qualified candidates have experience in regulated validation, aseptic processing, and cGMPs, with strong problem-solving, communication, and project management skills for multiple concurrent