Associate Process Engineer, MS&T

• 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 managemen

• 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.

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

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job.

The employee will be stationary (standing/sitting) occasionally.

Employees may need to wear clean room gowning or personal protective equipment based on the task being performed.

Must be able to work in a confined space, such as a clean room or laboratory environment.

Ability to identify small details within the field of vision, distinguish between different colors, and accurately identify objects within a specific area.

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.

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.

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

• A fully stocked kitchen with free snacks and beverages – we keep you energized and ready for what’s next.

Grow with us

• Ongoing professional development resources, training, and mentorship programs to help you build your care and grow within Forge.