Senior Process Engineer, MS&T

Forge Biologics•Columbus, OH

About The Position

The Senior Process Engineer is a senior technical leader within Manufacturing Science & Technology (MSAT), responsible for leading the implementation of complex biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role provides technical leadership for equipment and process introduction, technical transfer, engineering studies, and complex troubleshooting through commissioning and transition to manufacturing, ensuring systems are fit-for-purpose and ready for operation. This is a highly collaborative role that works closely with cross-functional teams including Process Development, Manufacturing, MSAT Operations, Validation, Quality, and external partners to ensure processes are scalable, robust, and aligned with global regulatory expectations.

Requirements

Bachelor’s degree in engineering or related technical discipline; Master's or PhD preferred
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.

Nice To Haves

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.

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.

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.