Forge Biologics

Sr. Project Engineer

Forge Biologics$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 7+ years of project engineering experience in capital project development and execution.
  • Bachelor's degree in Mechanical, Chemical, Electrical, or a related engineering field.
  • Experience in regulated industries (GMP, FDA, etc.).
  • Strong skills in budgeting, forecasting, and cost tracking.
  • Collaborative experience with internal departments and third-party contractors.
  • Proficiency in Microsoft Office, MS Project, AutoCAD, and engineering document management systems.
  • Familiarity with CMMS and Building Management Systems.

Responsibilities

  • Support mid-large scale CapEx projects from feasibility through start-up, ensuring site strategy alignment.
  • Serve as engineering Subject Matter Expert on complex projects, partnering with Internal PMO on major initiatives.
  • Develop and maintain key project documentation, ensuring compliance with engineering standards.
  • Establish NDAs and negotiate engineering contracts in partnership with Finance and Contracts.
  • Prepare and maintain engineering project schedules and cost estimates.
  • Lead project meetings to communicate status, timelines, and budget updates.
  • Provide field oversight of construction activities, ensuring quality and safety compliance.

Benefits

  • Collaborative work environment with exposure to complex projects.
  • Mentorship from senior engineers and opportunities for professional growth.
  • Engagement with cross-functional teams and external vendors.
  • Opportunity to lead innovative capital projects in a high-stakes environment.
Full Job Description
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

About Forge Biologics

Forge Biologics is a gene therapy contract development and manufacturing organization (CDMO) that focuses on the development and manufacturing of gene therapies for rare diseases. The company provides a full suite of services from preclinical development to commercial manufacturing. Forge Biologics is headquartered in North Canton, Ohio and was founded in 2019.
Learn more about Forge Biologics
Size
50 employees
Industry
Founded
2019

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