Project Engineer

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:

The Project Engineer is responsible for the development and execution of CapEx projects at the site. This position will lead or support projects from feasibility/conceptualization through detailed engineering, construction and start-up. The Project Engineer will be responsible for all applicable project documentation, adherence to budget and schedule all while maintaining the quality of the project. The Project Engineer will be responsible for engineering technical design decisions from project design through field installation and start-up.

What You’ll Do:

Leads or contributes to small to mid-size CapEx projects from feasibility through start-up, in alignment with the Site CapE strategy and Site Master Planning strategy.

Collaborates with the Internal PMO on complex projects and prepares governance documentation for large-scale initiatives. Acts as the engineering technical Subject Matter Expert (SME) on larger more complex projects.

Develops and maintains Project Charters, Project Execution Plans (PEPs), Scope of Work (SOW) documents, User Requirement Documents (URS) and other critical project documents, ensuring compliance with engineering standards.

Identifies required project team structure and resources; addresses gaps to ensure effective execution.

Establishes NDAs and negotiates appropriate engineering/design-build contracts in coordination with Finance and Contracts.

Prepares and maintains engineering project schedules and cost estimates (Rough Order of magnitude (ROM), Conceptual 25%, Basic 10%).

Leads project meetings to communicate status, timelines, and budget updates.

Partners with design-build firms to define scope, budgets, and timelines; leads competitive Request For Proposal (RFP) processes and identifies engineering documentation turnover package (ETOP) requirements needs early.

Maintains a field presence to monitor construction quality, escalate issues, and support resolution and improvement.

Supports or leads contractor safety programs and daily permitting (safe work, hot work, confined space).

Follows Project Change Order (PCO) and Engineering Change Notification (ECN) processes to manage scope, financial, and design changes.

Conducts or supports Technical Design Reviews (TDRs) and risk assessments (dFMEA, PHA, PSSR).

Drives project quality and change control activities to closure in compliance with site standards.

Manages relationships with key vendors; seeks new partners to support project execution and continuous improvement.

Coordinates with Plant Engineering and Maintenance to configure CMMS assets and maintenance needs.

Supports FAT/SAT processes.

Ensures proper documentation is incorporated into the EDMS including all aspects of engineering design, risk assessments, construction documentation, correspondence, schedules and financial information.

Leads or supports project closure and turnover documentation.

What You’ll Bring:

3+ years of experience in project engineering, facilities, or capital project development and execution.

Associate’s/Bachelor’s degree in Mechanical, Chemical, Electrical, or related Engineering field.

Experience working in a highly regulated industry (GMP, FDA, etc.)

Strong understanding of project budgeting, forecasting, and cost tracking.

Experience working collaboratively across departments and with third-party contractors (including contruction and trade contractors).

Proficiency in Microsoft Office, MS Project, AutoCAD, and engineering document management systems.

Familiarity with CMMS, Building Management Systems (BMS), and utility monitoring platforms.

Hands-on experience with the selection, specification, and procurement of mechanical equipment (e.g., chillers, AHUs, boilers, pumps, piping systems, clean utilities).

This role may require occasional weekend or off-hour work depending on project timelines.

Preferred: Experience in documentation management within a structured Quality System (ISO, FDA)

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

Physical Requirements:

May be required to lift up to 50 pounds of materials or equipment

Requirement to gown into Classified Areas of the facility (ISO 7 and 8 sterile gowning)

The ability to move safely over uneven terrain or in confined spaces

The ability to safely climb ladders while carrying 40 pounds

The ability to wear personal protective gear correctly as required

Work Environment and Physical Demands

This position works in both a warehouse and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The noise level in the work environment ranges from moderate to occasionally loud. Must be able to lift, carry, push, and/or pull objects weighing up to 35 lbs. Ability to frequently operate a computer, and communicate with others in person, over the phone, and via other devices. Must be able to move about the facility for moderate to extended periods of time. Ability to wear task dependent personal protective equipment as needed.

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