Senior Drug Product Engineer

Encodedgenomics; Morrisville (NC); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

PTO, sick time, holiday pay

Parental Leave program

Pre-tax medical benefits

STD, LTD, Life and AD&D

Wellness resources

Stocked micro-kitchen with drinks and

Team-building events

Job summary

Encoded Therapeutics Inc. seeks a Sr. Engineer in RTP, NC to lead design, implementation and lifecycle management of single-use manufacturing systems enabling cGMP Drug Product Manufacturing.

You will partner with Manufacturing, Process Sciences, QA and external vendors to drive compliant operations, qualification activities, and site readiness for commercial manufacturing, while maintaining a safe, efficient environment.

Qualifications

• Bachelor’s degree required; Mechanical, Chemical, or Bioengineering
• 10+ years in biotech/pharma/gene therapy engineering
• Experience with single-use tech and viral vector manufacturing
• GMP/cGMP manufacturing familiarity
• HVAC/utility systems and automation controls knowledge
• Strong cross-functional collaboration

Responsibilities

• Develop and apply engineering standards for facilities, utilities, maintenance and engineering
• Provide equipment and automation support for GMP manufacturing and GLP Process Science groups
• Oversee IQ/OQ/PQ, commissioning, and qualification activities
• Lead site engineering projects upgrades to facility, utility and automation systems
• Manage capital projects and site master plan for commercial manufacturing
• Ensure ongoing calibration, preventive maintenance and vendor contracts
• Coordinate with QA, Manufacturing, Process Sciences and Supply Chain

Job description

Locations:

Type:

Full time

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. 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
• Comprehensive benefits package, including competitive employer premium contributions
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• 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.