Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches.

This role will focus on the design, implementation and lifecycle management of single-use manufacturing systems and supporting infrastructure to successfully enable cGMP Drug Product Manufacturing capability. This role partners cross-functionally with Manufacturing, Process Sciences, Supply Chain, Quality Assurance and external vendors to ensure compliant and optimal operations. The successful candidate will work collaboratively across departments to lead engineering projects and maintain a safe and efficient working workplace.

Work as part of the Facilities, Utilities, Maintenance and Engineering (FUME) team on the development and application of engineering and automation standards and procedures Provide technical support for equipment and automation required for the internal GMP Manufacturing and GLP Process Science groups. This includes equipment specification, procurement, installation / start-up, testing, onboarding, and qualification (IQ, OQ, PQ activities) Provide training on new equipment and operations as needed Provide real-time manufacturing campaign support for internal Manufacturing and Process Sciences, including troubleshooting equipment/facilities-related issues and coordinating repairs with vendors (including off-hours/weekend support, if required)



Lead and manage site engineering projects including upgrades of facility, utility, and automation systems as well as GMP manufacturing and GLP analytical systems Manage engineering and facility capital projects. Support the development and implementation of the site master plan for the design / build effort to prepare for commercial manufacturing Perform or oversee building systems monitoring, including HVAC, electrical, plumbing, and utilities Follow internal EHS program guidelines to ensure effective and compliant operations in accordance with site registrations, cGMP and environmental regulations and state / federal requirements Assist in the development, continuous improvement and enforcement of site safety protocols and procedures Partner with Quality Assurance to ensure on-time creation and lifecycle management of Engineering documentation (SOPs, change controls, protocols, reports and GEP documentation) Maintain documentation, records, and reports related to site engineering and facilities management Education - Bachelor's degree in Engineering, specifically Mechanical Engineering, Chemical Engineering, or Bioengineering Experience - 10+ years of directly relevant experience in the biotech, pharmaceutical,



or gene therapy space Technical Knowledge - Proven expertise in facility, process, or manufacturing engineering in a biotech/pharmaceutical environment.

Technical troubleshooting abilities are required Technical Systems - Experience with HVAC and utility systems, as well as automation controls Regulatory Fluency - Deep understanding of cGMP systems and FDA/EU regulations Qualification Experience - Experience with IQ/OQ/PQ and commissioning and qualification activities Quality Systems - Experience with change control and CAPA/deviation support Collaboration - Experience partnering cross-functionally with Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, and coordinating with external vendors and service providers Travel - Ability to travel up to 10% for vendor visits or headquarters requirements Legal Authorization - Eligible to work in the United States PTO, sick time, and holiday pay Generous Parental Leave program Pre-tax medical and dependent care programs Team-building events Stocked micro-kitchen with drinks and snacks All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics.

📌 Senior Drug Product Engineer (Newfoundland and Labrador)
🏢 Encoded Therapeutics
📍 Newfoundland and Labrador