What are the responsibilities and job description for the Associate Process Engineer, MS&T position at Forge Biologics?
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 Job
As an Associate Process Engineer at Forge Biologics, you will be responsible for implementing new process equipment and optimizing gene therapy manufacturing processes within our Manufacturing Science and Technology (MS&T) department. This is a multidisciplinary position, and you will work closely with cross-functional teams, including R&D, manufacturing, quality, validation, facilities & engineering, and regulatory teams, to ensure that buffer prep, support functions, upstream, downstream, and fill finish processes are scalable, robust, and compliant with regulatory requirements. This role focuses on feasibility evaluations, equipment and process implementation, and documentation of engineering studies to support continuous improvement of processes towards the goals of process validation and the commercial manufacturing of gene therapy products. The Associate Process Engineering role also provides technical support and troubleshooting for assigned processes and equipment in the cGMP biological manufacturing areas, ensuring that all improvements are sustainable and aligned with overall business goals.
What You'll Do
What You'll Bring
This position works in a typical office environment where the physical demand varies depending on the specific tasks and duties assigned. The employee may be stationary (standing/sitting) for extended periods of time. The employee will be made aware and acknowledge established procedures regarding personal protective equipment and safety requirements specific to the company. Must be able to work in an office space and trained & qualified to enter a production suite(s) or laboratory environment for general understanding of the business.
Work Environment
The work environment is fast paced. This position has the utmost responsibility for comprehending biologics manufacturing compliance with procedures and regulations regarding a safe and collaborative work environment relative to actions and conduct. Other duties may be assigned in addition to those described that aligns with company objectives.
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.
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
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 Job
As an Associate Process Engineer at Forge Biologics, you will be responsible for implementing new process equipment and optimizing gene therapy manufacturing processes within our Manufacturing Science and Technology (MS&T) department. This is a multidisciplinary position, and you will work closely with cross-functional teams, including R&D, manufacturing, quality, validation, facilities & engineering, and regulatory teams, to ensure that buffer prep, support functions, upstream, downstream, and fill finish processes are scalable, robust, and compliant with regulatory requirements. This role focuses on feasibility evaluations, equipment and process implementation, and documentation of engineering studies to support continuous improvement of processes towards the goals of process validation and the commercial manufacturing of gene therapy products. The Associate Process Engineering role also provides technical support and troubleshooting for assigned processes and equipment in the cGMP biological manufacturing areas, ensuring that all improvements are sustainable and aligned with overall business goals.
What You'll Do
- Support engineering studies and continuous improvement projects in partnership with Manufacturing, Validation, Quality Engineering, and/or Process Development to drive operational efficiency, reduce costs, and enhance product consistency.
- Contribute to Technology Transfer (TT) activities, including equipment gap assessments, process mapping, new system implementation, and pFMEAs to ensure smooth and efficient technology transfer of gene therapy processes into manufacturing.
- Assist in the development of project justification, engineering proposals, and capital planning processes, including drafting URS and SIA documentation, facilities and equipment selection, and development of maintenance and training plans.
- For new equipment, may participate and/or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and IQ/OQ/PQ.
- Support troubleshooting technical issues, identifying root causes, and supporting implementation of corrective/preventative action plans related to equipment and automation.
- Create and update operation and maintenance documentation, including SOPs and training materials, for process and automated systems.
- Support Senior Engineers on complex projects and continuous improvement initiatives.
- Provide on-call support for process equipment as needed.
- Listens attentively to internal departments and team members to relay information, responsibilities, and policies respectfully, effectively, and clearly.
- Builds sound working relationships with internal departments and external clients in support of company goals.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
What You'll Bring
- Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field with 1 years of experience in MS&T, Process Development, or GMP Manufacturing Operations.
- Possess some technical skills and knowledge of a focus area of drug substance manufacturing and/or drug product manufacturing, process/utility equipment, and automated systems.
- Possess some understanding of engineering drawings, Piping and instrumentation diagrams (P&IDs), SOPs, vendor documentation, and other technical documentation.
- Strong analytical and problem-solving skills
- Excellent communication and teamwork abilities
- Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.
- Prior experience in gene therapy manufacturing.
This position works in a typical office environment where the physical demand varies depending on the specific tasks and duties assigned. The employee may be stationary (standing/sitting) for extended periods of time. The employee will be made aware and acknowledge established procedures regarding personal protective equipment and safety requirements specific to the company. Must be able to work in an office space and trained & qualified to enter a production suite(s) or laboratory environment for general understanding of the business.
Work Environment
The work environment is fast paced. This position has the utmost responsibility for comprehending biologics manufacturing compliance with procedures and regulations regarding a safe and collaborative work environment relative to actions and conduct. Other duties may be assigned in addition to those described that aligns with company objectives.
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.
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
