Encoded Therapeutics

Precision gene therapies for pediatric CNS.

Senior Process Engineer - Drug Product

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeMorrisville, NC, USA

About the Job

Requirements

A Bachelor's degree in Mechanical Engineering, Chemical Engineering, or Bioengineering is required.
At least 10 years of directly relevant experience in the biotechnology, pharmaceutical, or gene therapy industry is required.
Proven expertise in facility, process, or manufacturing engineering in a biotechnology or pharmaceutical environment is required.
Experience designing and operating drug product sterile filling equipment is required.
Technical troubleshooting ability is required.
Experience with HVAC and utility systems and automation controls is required.
A deep understanding of current Good Manufacturing Practice (cGMP) systems and FDA and EU regulations is required.
Experience with IQ/OQ/PQ and commissioning and qualification activities is required.
Experience with change control and corrective and preventive action (CAPA)/deviation support is required.
Experience with preventive maintenance and calibration programs is required.
Experience partnering with Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, and coordinating with external vendors and service providers is required.
Ability to provide on-call or in-person support for batch processing operations, including occasional off-hours troubleshooting, is required.
Ability to travel up to 10% for vendor visits or headquarters requirements is required.
Eligibility to work in the United States is required.

Responsibilities

Work as part of the Facilities, Utilities, Maintenance and Engineering (FUME) team to develop and apply engineering and automation standards and procedures.
Provide technical support for equipment and automation required by internal Good Manufacturing Practice (GMP) Manufacturing and Good Laboratory Practice (GLP) Process Science groups, including equipment specification, procurement, installation and start-up, testing, onboarding, and qualification activities (IQ, OQ, and PQ).
Provide training on new equipment and operations as needed.
Provide real-time manufacturing campaign support for internal Manufacturing and Process Sciences, including troubleshooting equipment- and facility-related issues and coordinating repairs with vendors, including off-hours or weekend support when required.
Maintain the validated state of equipment through preventive maintenance and calibration management systems, including creating and renewing vendor service and calibration contracts and scheduling and overseeing services.
Lead and manage site engineering projects, including upgrades to facility, utility, and automation systems, as well as GMP manufacturing and GLP analytical systems.
Manage engineering and facility capital projects.
Support development and implementation of the site master plan for the design and build effort to prepare for commercial manufacturing.
Perform or oversee building systems monitoring, including HVAC, electrical, plumbing, and utilities.
Follow internal environmental, health, and safety (EHS) program guidelines to ensure effective and compliant operations in accordance with site registrations, cGMP and environmental regulations, and state and federal requirements.
Assist in developing, continuously improving, and enforcing site safety protocols and procedures.
Ensure adherence to Good Practice (GxP) guidelines as indicated by the phase of manufacture.
Partner with Quality Assurance to ensure timely creation and lifecycle management of engineering documentation, including standard operating procedures (SOPs), change controls, protocols, reports, and Good Engineering Practice (GEP) documentation.
Maintain documentation, records, and reports related to site engineering and facilities management.

Desired Qualifications

Experience with single-use technology and viral vector manufacturing is highly preferred.

Sr. Process Engineer - Drug Product

Encoded Therapeutics · Morrisville, United States · Full-time · Posted 2026-11-06

Workplace: on_site

Department: Facilities & Engineering

Description

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. For more information, please visit www.Encoded.com.

Role Description

We are seeking an experienced Sr. Process Engineer to join our rapidly growing team based in RTP, NC. 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 environment.

Responsibilities

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)
Ensure validated state of equipment is maintained through preventative maintenance and calibration management systems, including creation and renewal of vendor service and calibration contracts and scheduling / overseeing services
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
Ensure adherence to GxP guidelines as indicated by phase of manufacture
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

Requirements

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. Experience with single-use technology and viral vector manufacturing is highly preferred. Drug product sterile filling equipment design and operations experience is required. 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
Maintenance Programs - Experience with preventive maintenance and calibration programs
Collaboration - Experience partnering cross-functionally with Manufacturing, Process Sciences, Supply Chain, and Quality Assurance, and coordinating with external vendors and service providers
Operational Flexibility - Ability to provide on-call or in-person support for batch processing operations, including occasional off-hours troubleshooting
Travel - Ability to travel up to 10% for vendor visits or headquarters requirements
Legal Authorization - Eligible to work in the United States

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
STD, LTD, Life and AD&D
Professional development opportunities
Team-building events
Stocked micro-kitchen with drinks and snacks
Wellness Resources

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. 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. Encoded encourages applicants of all ages.

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About the Company

Encoded Therapeutics

Precision gene therapies for pediatric CNS.

Encoded Therapeutics develops precision gene therapies for pediatric CNS disorders such as Dravet syndrome, using a targeting and regulation platform that directs genetic payloads to specific brain cell types based on genetic profiles. The approach aims to increase gene specificity, cell selectivity, and potency, while reducing off-target effects and toxicity. Therapies are designed to modify disease-causing genes in defined brain cells to provide lasting benefits. The company plans to translate these therapies into clinically effective treatments and commercialize them through partnerships with healthcare providers.

Company size: 51-200
Company stage: Series F
Total funding: $514.1M
Headquarters: San Francisco, CA
Founded: 2014

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