Associate Process Engineer, MS&T

Forge Biologics • Columbus, OH

21h • Onsite

About The Position

The Associate Process Engineer (Drug Product) is an entry level technical contributor within Manufacturing Science and Technology (MS&T), responsible for supporting implementation and sustainment of biopharmaceutical equipment and processes supporting gene therapy manufacturing. This role supports equipment and process introduction, technical transfer activities, engineering studies, and troubleshooting under the guidance of senior engineering staff to ensure systems are fit- for-purpose and ready for operations. 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 life sciences, engineering or related field and 1+ years of experience, Master’s degree with 0-1+ years of experience
• Demonstrates foundational technical knowledge in at least one focus area related to drug substance and/or drug product manufacturing, process or utility equipment, or automated systems.
• Demonstrated basic ability to interpret and utilize technical documentation including engineering drawings, piping and instrumentation diagrams (P&IDs), SOPs, vendor documentation, and equipment manuals.
• Strong organization and communication skills
• Strong attention to detail and ability to maintain accurate GMP documentation
• Commitment to following SOPs, safety protocols, and regulatory guidelines to ensure compliance and product quality.

Nice To Haves

• Prior experience in biologics or gene therapy manufacturing.
• Familiarity with electronic documentation systems or data analysis tools.

Responsibilities

• Support execution engineering studies to evaluate equipment performance, optimize process parameters, and assist with engineering controls supporting operational readiness.
• Assist with authoring and revising technical documentation including engineering studies, SOPs, protocols, and technical reports.
• Support technology transfer activities including documentation support, process flow mapping, and participation in risk assessments.
• Support commissioning and qualification activities including equipment documentation (URS), factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, and vendor IQ/OQ.
• Support equipment troubleshooting activities and vendor interactions under guidance of senior engineering staff.
• Provide technical support to Manufacturing for routine operations, new process implementation, and equipment readiness activities.
• Support investigations related to process or equipment performance and assist with implementation of corrective actions.
• Ensure processes meet all regulatory guidelines (FDA, EMA, ICH, etc.) and quality system requirements (cGMP).
• Build collaborative working relationships with internal stakeholders to drive the business towards achieving company objectives.
• Exhibits professional behavior 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
• 12 weeks of fully paid parental leave
• Annual bonus opportunities for all full-time team members.
• 401(k) with company match
• 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
• A fully stocked kitchen with free snacks and beverages
• Ongoing professional development resources, training, and mentorship programs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level