Engineer III, Site Engineering & Facilities

Encoded Therapeutics Inc

Morrisville, NC

JOB DETAILS
SKILLS
Automation, Biotech and Pharmaceutical, Calibration, Campaigns, Capital Project, Change Control, Contract Review, Cross-Functional, Current Good Manufacturing Practice (cGMP), Disease, Document Management, Documentation, Engineering Management, GEP (Good Engineering Practices), Gene Therapy, Genetic Programming, Genetics, Identify Issues, Manufacturing, Manufacturing Operations, Manufacturing Systems, Manufacturing/Industrial Processes, Medical Products, Neurology, On Call, On Site Support, Onboarding, Operations Processes, Preventative Maintenance, Process Validation, Procurement Management, Procurement Specifications, Project Design, QA Partner Testing Software, Quality Assurance, Regulations, Standard Operating Procedures (SOP), Standards Development, Supply Chain, Technical Support, Technical Training, Vendor/Supplier Management
LOCATION
Morrisville, NC
POSTED
23 days ago

Encoded Therapeutics is a clinical-stage biotechnology company developing precision genetic medicines to transform the lives of patients with severe neurological disorders. The companys 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. For more information, please visit www.encoded.com.

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.

CoreResponsibilities:

Engineering Standards & Automation

  • Standard Development: Serve as a core member of the FUME team, contributing to the creation and application of site-wide engineering and automation standards.
  • Capital Support: Provide technical support for site engineering and facility capital projects. Take ownership of small-scale projects, managing design, procurement, and implementation.

Equipment Lifecycle Management

  • Technical Execution: Execute the full lifecycle of automation and equipment for internal groups, including specification, procurement, testing, onboarding, and qualification (IQ/OQ/PQ).
  • Validation & Maintenance: Sustain the validated state of site equipment through robust preventative maintenance and calibration systems.
  • Vendor Management: Manage vendor service and calibration contracts, review turnover packages, and coordinate on-site service schedules.

Manufacturing Operations & Compliance

  • Manufacturing Support: Deliver real-time troubleshooting for active manufacturing campaigns. Coordinate repairs with external vendors to minimize downtime (includes on-call/weekend support as needed).
  • Quality Documentation: Partner with QA to lead the lifecycle management of engineering documentation, including SOPs, Change Controls, and GEP (Good Engineering Practice) protocols.
  • EHS & Regulatory: Maintain 100% compliance with internal EHS guidelines, site registrations, and cGMP/environmental regulations.

Training & Mentorship

  • Skill Development: Act as a subject matter expert (SME) by providing technical training on new equipment and operational procedures to the wider site team.

About the Company

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Encoded Therapeutics Inc