Forge Biologics · 14 hours ago
Senior Process Engineer, MS&T
Columbus, OH
Full-time
Onsite
Senior Level
5+ years expForge Biologics is dedicated to enabling access to life-changing gene therapies. The Senior Process Engineer will lead the implementation of complex biopharmaceutical equipment and processes, ensuring systems are fit-for-purpose and ready for operation while collaborating with cross-functional teams to optimize gene therapy manufacturing.
BiotechnologyHealth CareMedicalTherapeutics
Responsibilities
Serve as a technical lead for upstream and downstream process equipment, identifying and supporting introduction of new systems or engineering-based improvements to equipment and facility system. This may include developing the technical justification and business case, translation of process requirements into equipment and system specifications, and supporting startup, and transition to GMP operations
Lead the planning, execution, and documentation of engineering studies to evaluate equipment performance, optimize recipe parameters, and develop engineering controls to support operational readiness
Partner with clients and internal cross functional teams in technology transfer plans, gap analysis, mapping of process flows, and FMEAs to ensure smooth and efficient technology transfer of gene therapy processes into manufacturing
Identify and implement continuous process optimizations, automation, and new technology to drive operational efficiency, reduce costs, and enhance product consistency
Support product lifecycle management incorporating phase appropriate requirements and develop process control strategies in preparation for process qualification
Support the development of technical documents such as study plans, manufacturing batch records, and SOPs, protocols, and reports
For new equipment, may participate and/or be responsible for factory acceptance testing (FAT), site acceptance testing (SAT), and commissioning
May participate in external as well as internal audits of the manufacturing facilities and processes
Assist in root cause investigations related to equipment and process performance and define sustainable corrective actions
Mentor process engineer team members, supporting technical and professional development
Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP)
Builds effective partnerships with internal stakeholders to drive the business towards achieving company objectives
Exhibits professional behavior with both internal and external business associates that reflects positively on the company and is consistent with company policies and cultural values
Additional responsibilities not listed may be assigned as needed by management
Qualification
Required
Bachelor's degree in engineering or related technical discipline
5-8+ years of experience of relevant GMP engineering or manufacturing experience in biopharmaceutical or gene therapy environments
Deep technical knowledge of GMP manufacturing equipment and unit operations (e.g., bioreactors, chromatography, TFF, centrifugation, aseptic processing)
Demonstrated experience leading cross-functional technical initiatives and capital projects
Strong knowledge of regulatory requirements and validation processes
Excellent problem-solving, analytical, and strategic thinking skills
Effective communication and cross-functional collaboration abilities
Preferred
Experience supporting late-stage clinical or commercial manufacturing
Prior system ownership responsibility for GMP equipment or processes
Demonstrated mentorship or technical leadership within an engineering or MSAT organization
Benefits
Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
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.
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.
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.
A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.
Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.
Company
Forge Biologics
Forge Biologics is a gene therapy development engine, enabling access to life changing gene therapy programs.
201-500 employees
H1B Sponsorship
Forge Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (2)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$330MKey Investors
State of OhioMidCap FinancialRA Capital Management
2023-11-13Acquired
2022-09-12Series C· $90M
2022-01-10Grant
Leadership Team
Timothy J. Miller, Ph.D. (he/him)
Cofounder, President & CEO
Erandi De Silva, PhD
Co-founder, Senior Vice President of Product Development
Recent News
2025-12-24
Company data provided by crunchbase