Senior Drug Product Engineer

About the role

Encoded Therapeutics, a biotechnology company focused on viral gene therapy, is looking for an experienced Senior Drug Product Engineer to join its Facilities & Engineering team in RTP, NC. The role covers the design, implementation and lifecycle management of single-use manufacturing systems and supporting infrastructure to enable cGMP drug product manufacturing, working with Manufacturing, Process Sciences, Supply Chain, Quality Assurance and external vendors.

Key responsibilities

• Work with the FUME team on engineering and automation standards and procedures
• Support equipment and automation for GMP manufacturing and GLP process science, including specification, procurement, installation, testing, onboarding and qualification (IQ, OQ, PQ)
• Train staff on new equipment and operations, and support manufacturing campaigns with troubleshooting and vendor coordination
• Maintain validated equipment through preventive maintenance and calibration, including vendor and calibration contracts
• Lead engineering projects such as facility, utility and automation upgrades, and manage capital projects and the site master plan for commercial manufacturing
• Oversee building systems monitoring (HVAC, electrical, plumbing, utilities) and follow EHS and cGMP compliance
• Partner with Quality Assurance on engineering documentation (SOPs, change controls, protocols, reports) and keep engineering records

Required profile

• Bachelor's degree in Mechanical, Chemical or Bioengineering
• 10+ years of directly relevant experience in biotech, pharmaceutical or gene therapy
• Experience partnering with Manufacturing, Process Sciences, Supply Chain and Quality Assurance, and with external vendors
• Ability to provide on-call or in-person support for batch processing, including occasional off-hours work, and to travel up to 10%
• Eligible to work in the United States

Required skills

• Proven facility, process or manufacturing engineering experience; single-use technology and viral vector manufacturing highly preferred; drug product sterile filling equipment design and operations required
• HVAC and utility systems, and automation controls
• cGMP systems and FDA/EU regulations
• IQ/OQ/PQ, commissioning, change control, CAPA and deviation support, preventive maintenance and calibration programs

What we offer

• Comprehensive benefits with competitive employer premium contributions
• Stock option grants
• PTO, sick time, holiday pay and parental leave
• Pre-tax medical and dependent care programs, STD, LTD, life and AD&D insurance
• Professional development, team-building events and a stocked micro-kitchen