Sr. Validation Engineer

Job Description

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 Senior Validation Engineer to join the Forge Biologics team. As a Sr. Validation Engineer, you will be responsible for the design, implementation, and execution of process 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 process validation and aseptic process simulation to ensure adherence to regulatory compliance and industry best practices.

What You'll Do

Develop, Implement, and Maintain the Process Performance Qualification (PPQ) and Continued Process Validation (CPV) programs, including development of related procedures, templates, work instructions, and associated documentation.

Develop and lead execution of Process Performance Qualification (PPQ) protocols, for GMP manufacturing processes.

Maintain and provide continuous improvement of the Aseptic Process Simulation (APS) (Media Fill) program.

Develop and lead execution of new aseptic (APS) protocols, for aseptic manufacturing processes.

Collaborate with cross-functional teams, including Process & Analytical Development, GMP Manufacturing, Operations, Manufacturing Science and Technology (MSAT), Quality Management, Quality Control, and Regulatory Affairs to ensure effective planning, execution, and completion of validation activities.

Define sampling plans and, test methods, and acceptance criteria for validation deliverables, ensuring alignment with regulatory guidelines (FDA, EMA, etc.), industry best practices, and internal procedures.

Lead and participate in investigations related to validation deviations, implementing appropriate corrective and preventive actions (CAPAs) as needed.

Assess changes to proposed process changes and develop validation plans, as necessary.

Conduct hands-on validation activities, such as protocol generation, execution, data analysis, and report writing.

Collaborate on risk management, process development studies, technology transfer, and other process validation related activities.

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

Provide technical guidance and mentorship to junior team members, fostering a culture of knowledge sharing and professional development.

Support Equipment, Facility, and Utility Commissioning and Qualification efforts, as necessary.

What You'll Bring

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

Knowledge of validation principles across multiple disciplines, which may include process validation, aseptic process simulation, equipment qualification, and/or computer systems.

Significant experience in process validation within the pharmaceutical or biotechnology industry.

Strong understanding of Quality by Design (QbD) principles with proficiency in risk assessment methodologies (e.g., PFMEA) and statistical analysis tools for validation data (e.g., Minitab, JMP).

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.

Experience in the application of commercial cGMPs.

Experience with aseptic processing and clean room standards.

Ability to work onsite (Columbus, Ohio) 4-5 days/week on average.

Preferred

Process Validation experience in the Cell & Gene Therapy Industry.

Experience in qualifying a wide range of equipment, including Biological Safety Cabinets (BSCs), Controlled Temperature Units (CTUs), bioreactors, incubators, chromatography systems, centrifuges, and analytical instruments.

Experience in the application of pre-clinical and clinical cGMPs.

Experience with Cleaning Validation.

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

Competitive Paid Time Off plan

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)

Onsite fitness facility

Professional & Personal development resources

Full-time