Engineer III, Site Engineering & Facilities

Encoded Therapeutics•Morrisville, NC

2d•Onsite

About The Position

Encoded Therapeutics is a clinical-stage biotechnology company developing precision genetic medicines to transform the lives of patients with severe neurological disorders. The company’s vector engineering platform enables potent and cell-type-selective regulation of gene expression, allowing for targeted modulation of disease-relevant genes. Encoded is advancing a pipeline of programs across genetic epilepsies and other neurological disorders with significant unmet need. With integrated discovery, development, and manufacturing capabilities, Encoded is positioned to efficiently move programs from concept through the clinic. Encoded is driven by a mission to meaningfully improve the lives of patients and families affected by devastating neurological disorders. As an Engineer III, Site Engineering & Facilities, you will be a key technical driver in the design, implementation, and lifecycle management of single-use manufacturing systems within our gene therapy production facility. This role serves as a vital cross-functional partner to Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, ensuring that our viral vector production remains compliant, efficient, and innovative within a cGMP environment.

Requirements

Bachelor’s degree in Engineering (Mechanical, Chemical, or Bioengineering preferred).
5-9 years of directly relevant experience in the biotech, pharmaceutical, or gene therapy space.
Proven expertise in facility, process, or manufacturing engineering.
Single-use technology and viral vector manufacturing experience is highly preferred.
Deep understanding of cGMP systems and FDA/EU regulations.
Ability to provide on-call or in-person support for batch processing operations.
Strong troubleshooting, organizational, and interpersonal skills.
Must be a proactive team player.
Ability to travel up to 10% for vendor visits or headquarters requirements.

Nice To Haves

Single-use technology and viral vector manufacturing experience

Responsibilities

Serve as a core member of the FUME team, contributing to the creation and application of site-wide engineering and automation standards.
Provide technical support for site engineering and facility capital projects. Take ownership of small-scale projects, managing design, procurement, and implementation.
Execute the full lifecycle of automation and equipment for internal groups, including specification, procurement, testing, onboarding, and qualification (IQ/OQ/PQ).
Sustain the validated state of site equipment through robust preventative maintenance and calibration systems.
Manage vendor service and calibration contracts, review turnover packages, and coordinate on-site service schedules.
Deliver real-time troubleshooting for active manufacturing campaigns. Coordinate repairs with external vendors to minimize downtime (includes on-call/weekend support as needed).
Partner with QA to lead the lifecycle management of engineering documentation, including SOPs, Change Controls, and GEP (Good Engineering Practice) protocols.
Maintain 100% compliance with internal EHS guidelines, site registrations, and cGMP/environmental regulations.
Act as a subject matter expert (SME) by providing technical training on new equipment and operational procedures to the wider site team.