Sr. Process Engineer - Drug Product
About The Position
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for genetic disorders through genomics-driven discovery and viral gene therapy. The Sr. Process Engineer will join the team in RTP, North Carolina, focusing on the design, implementation, and lifecycle management of single-use manufacturing systems and supporting infrastructure for cGMP Drug Product Manufacturing. The role works cross-functionally with Manufacturing, Process Sciences, Supply Chain, Quality Assurance, and external vendors to enable compliant, effective operations and maintain a safe and efficient work environment. As part of the Facilities, Utilities, Maintenance and Engineering (FUME) team, the engineer provides technical support for GMP Manufacturing and GLP Process Science equipment and automation, leads engineering and capital projects, supports manufacturing campaigns, and maintains equipment and facility systems in a validated state. The position also supports the site master plan for commercial manufacturing readiness and partners with Quality Assurance on engineering documentation and lifecycle management.
Requirements
- Bachelor's degree in Mechanical Engineering, Chemical Engineering, Bioengineering, or another specified engineering discipline.
- At least 10 years of directly relevant experience in biotechnology, pharmaceuticals, or gene therapy.
- Proven expertise in facility, process, or manufacturing engineering in a biotechnology or pharmaceutical environment.
- Experience with drug product sterile filling equipment design and operations.
- Technical troubleshooting abilities.
- Experience with HVAC and utility systems and automation controls.
- Deep understanding of cGMP systems and FDA/EU regulations.
- Experience with IQ/OQ/PQ and commissioning and qualification activities.
- Experience with change control and CAPA/deviation support.
- Experience with preventive maintenance and calibration programs.
- Experience working cross-functionally with Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, and coordinating with external vendors and service providers.
- Ability to provide on-call or in-person support for batch processing operations, including occasional off-hours troubleshooting.
- Ability to travel up to 10% for vendor visits or headquarters requirements.
- Eligible to work in the United States.
Nice To Haves
- Experience with single-use technology and viral vector manufacturing is highly preferred.
Responsibilities
- Develop and apply engineering and automation standards and procedures as part of the FUME team.
- Provide technical support for equipment and automation used by GMP Manufacturing and GLP Process Science, including specification, procurement, installation and start-up, testing, onboarding, and IQ/OQ/PQ qualification activities.
- Train staff on new equipment and operations as needed.
- Provide real-time manufacturing campaign support, troubleshoot equipment and facility issues, and coordinate vendor repairs, including off-hours or weekend support when required.
- Maintain the validated state of equipment through preventive maintenance and calibration systems, including managing service and calibration contracts and overseeing scheduled services.
- Lead site engineering projects involving facility, utility, automation, GMP manufacturing, and GLP analytical systems.
- Manage engineering and facility capital projects and support development and implementation of the site master plan for commercial manufacturing design and build.
- Perform or oversee monitoring of building systems, including HVAC, electrical, plumbing, and utilities.
- Follow internal EHS guidelines and ensure operations comply with site registrations, cGMP, environmental regulations, and state and federal requirements.
- Assist with developing, improving, and enforcing site safety protocols and procedures.
- Ensure adherence to GxP guidelines appropriate to the manufacturing phase.
- Partner with Quality Assurance on timely creation and lifecycle management of engineering documentation, including SOPs, change controls, protocols, reports, and GEP documentation.
- Maintain records, reports, and other documentation related to site engineering and facilities management.
Benefits
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time, and holiday pay
- Generous parental leave program
- Pre-tax medical and dependent care programs
- Short-term disability, long-term disability, life, and AD&D coverage
- Professional development opportunities
- Team-building events
- Stocked micro-kitchen with drinks and snacks
- Wellness resources
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What This Job Offers
Job Type
Full-time
Career Level
Senior
