Validation Engineer II

About Forge

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine, focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role

We are currently looking for a highly skilled and experienced Validation Engineer to join the Forge Biologics team. As a Validation Engineer II, you will be responsible for the design, implementation, and execution of equipment validation activities to ensure the compliance, quality, and efficacy of our manufacturing processes. You will work closely with cross-functional teams to develop and execute validation strategies, provide technical expertise in equipment validation, and ensure adherence to regulatory requirements.

What You'll Do

• Develop and execute equipment validation protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing equipment.

• Develop, review, approve, and/or support Commissioning & Qualification (C&Q) lifecycle documentation including, User Requirement Specifications (URS), Good Automated Manufacturing Practices (GAMP) Assessments, Part 11 Compliance Assessments, and Design Qualifications (DQ).

• Define acceptance criteria and develop test methods for equipment qualification, ensuring alignment with regulatory guidelines (FDA, EU, etc.) and industry best practices.

• Collaborate with cross-functional teams, including Process Development, Manufacturing, Quality, and Engineering to ensure effective planning, execution, and completion of equipment validation activities.

• Lead and participate in investigations related to equipment validation deviations, non-conformances, and out-of-specification results, implementing appropriate corrective and preventive actions (CAPAs) as needed.

• Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing, ensuring compliance with regulatory requirements and internal quality standards.

• Stay abreast of industry trends, regulatory updates, and technological advancements related to equipment validation in the cell and gene therapy field, and propose continuous improvement initiatives to enhance validation processes and practices.

• Provide technical guidance other team members and functional teams, fostering a culture of knowledge sharing and professional development.

What You'll Bring

• Bachelor's or degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field (or equivalent experience).

• Significant experience in equipment validation within the pharmaceutical or biotechnology industry.

• Experience in qualifying a wide range of equipment, including Isolators, Filling & Capping equipment, Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, and centrifuges.

• Experience with aseptic processing and clean room standards.

• Proficiency in risk assessment methodologies.

• Strong understanding of cGMPs (current Good Manufacturing Practices).

• Excellent analytical, problem-solving, and decision-making skills, with meticulous attention to detail.

• Effective communication and collaboration abilities, with the capacity to work cross-functionally and influence stakeholders at various levels of the organization.

• Strong project management skills, with the ability to prioritize and manage multiple validation projects concurrently.

Preferred Skills

• Experience in the Cell & Gene Therapy industry.

• Knowledge of validation principles across multiple disciplines, which may include computerized systems, aseptic process simulation, and/or process validation.

• Experience in the application of pre-clinical, clinical, and commercial cGMPs.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

• Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents

• Flexible PTO (plus 14 paid company holidays)

• Annual bonus for all full-time employees

• 401(K) company match

• Fully-stocked kitchen with free food/drinks

• 12 weeks of paid parental leave - additional discount programs include childcare support & dependent care

• Employee Assistance Program

• Wellness benefits (financial planning services, mental health counseling, employer paid disability)

• Professional & Personal development resources - LinkedIn Learning, a dedicate training staff in-house, mentoring opportunities & access to leadership development coaches