Sr. Project Engineer

Forge Biologics

North Carolina

On-site

USD 110,000 - 150,000

Full time

14 days+

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Benefits offered by this job

Health insurance

PTO

Parental leave

Annual bonus

401(k) match

Employee discounts

Onsite gym

Mental health support

Disability coverage

Free snacks

Job summary

Forge Biologics in Columbus, Ohio is seeking a Sr. Project Engineer to lead capex projects from feasibility through start-up. You will manage budgets, schedules, and project documentation, and provide field oversight of construction, commissioning, and turnover.

As the engineering SME, you will partner with internal PMO, vendors and design-build teams to define scope, budgets and timelines; drive governance, change control and risk assessments, and ensure compliance with GMP/FDA standards.

Qualifications

7+ years of experience in project engineering, facilities, or capital project development and execution.
Bachelor’s degree in Mechanical, Chemical, Electrical, or related Engineering field.
Experience in a highly regulated environment (GMP, FDA) and with budgeting/cost tracking.

Responsibilities

Supports mid-large scale CapEx projects from feasibility through start-up, aligning with site strategies.
Serve as engineering SME on complex projects, partnering with internal PMO and preparing governance documentation.
Develops and maintains Project Charters, PEPs, SOWs and critical project documents; ensures compliance with standards.
Establishes NDAs and negotiates engineering/design-build contracts with Finance and Contracts.
Prepares and maintains project schedules and ROM cost estimates; communicates status and budget updates.
Leads meetings with design-build firms; defines scope, budgets, and timelines; manages RFP processes; ensures timely turnover.

Skills

Project budgeting

Vendor management

MS Project

AutoCAD

GMP/FDA knowledge

Education

Bachelor’s degree in Engineering

Tools

CMMS

BMS

EDMS

Job description

Forge Your Future with Us:

At Forge Biologics, we believe in turning bold ideas into life-changing realities. Our mission is simple yet powerful: to enable access to life-changing gene therapies and help bring them from ideas into reality. We partner with scientists, physicians, biotech and pharma innovators, and patient communities — all united by one goal: improving lives. If you’re driven by purpose and excited to make a tangible impact, this is where your journey begins.

Our team works out of The Hearth, a state-of-the-art, 200,000-square-foot cGMP facility in Columbus, Ohio. Here, you won’t just watch innovation happen — you’ll be part of it. Whether you’re scaling AAV manufacturing, collaborating on cutting-edge therapies, or supporting complex technical projects, you’ll play a key role in bringing hope to patients with genetic diseases.

What sets Forge apart is our culture of H.O.P.E. We are hardworking , showing up each day with determination and grit. We are open , creating a space where ideas flow freely, and every voice is valued. We are purpose-driven , with every task directly tied to changing lives. And we are engaged , energized by the challenges we face and the milestones we achieve together.

At Forge, your growth matters. We’re committed to helping you expand your skills, take on new challenges, and develop your career through mentorship, hands-on learning, and opportunities for advancement. Our people are our greatest investment, and we’re proud to see team members grow with us.

If you’re ready to use your talent to help deliver hope to patients around the world, join us — and be part of something bigger than yourself.

About The Role:

The Sr. 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 role will be responsible for all applicable project documentation, adherence to budget and schedule all while maintaining the quality of the project. The Sr. Project Engineer will be responsible for engineering technical design decisions from project design through field installation and start‑up.

Responsibilities:

Supports mid-large scale CapEx projects from feasibility through start‑up, ensuring alignment with site CapEx and Site Master Planning strategies.
Serve as the engineering Subject Matter Expert (SME) on complex projects, partnering with the Internal PMO on complex projects and preparing governance documentation for major initiatives.
Develops and maintains Project Charters, Project Execution Plans (PEPs), Scope of Work (SOW) documents, User Requirement Documents and other critical project documents, ensuring compliance with engineering standards.
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).
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.
Provide field oversight of construction activities, ensuring quality, safety, permitting compliance, and timely resolution of project issues.
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 vendors; seeks new partners to support project execution and continuous improvement.
Coordinate with Plant Engineering and Maintenance to support CMMS asset configuration, maintenance planning, and FAT/SAT processes to ensure operational readiness and successful project handoff.
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.

Qualifications:

7+ years of experience in project engineering, facilities, or capital project development and execution.
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.
This role may require occasional weekend or off‑hour work depending on project timelines.
Ability to work onsite (Columbus, Ohio) 4 days/week on average.

Preferred Skills:

Experience in documentation management within a structured Quality Management System (ISO, FDA).
Hands‑on experience with the selection, specification, and procurement of mechanical equipment (e.g., chillers, AHUs, boilers, pumps, piping systems, clean utilities).

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.

Work Environment and Physical Demands

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

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.

We’ve Got You Covered:

At Forge Biologics, we believe our people deserve to be taken care of – in and out of the workplace. We’ve built a comprehensive compensation and benefits package designed to help you thrive, grow, and feel valued every step of the way:

Health from day one

Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.

Time to recharge

A competitive paid time off plan – because rest fuels innovation.
12 weeks of fully paid parental leave so you can focus on family when it matters most.

Rewarding your impact

Annual bonus opportunities for all full‑time team members.
401(k) with company match to help you plan for the future.
Special employee discounts, including childcare and dependent care savings.

Your wellness, supported

Onsite fitness facility at The Hearth.
Mental health counseling and financial planning services through our Employee Assistance Program.
Employer‑paid short and long‑term disability coverage to protect your peace of mind.

Fuel for your workday