Senior Biotech GMP Drug Product Engineer

Encoded Therapeutics Inc.; Morrisville (NC); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Stock options

PTO, sick time, holidays

Parental Leave

Pre-tax medical & dependent care

STD/LTD/Life & AD&D

Professional development

Job summary

Encoded Therapeutics Inc. in RTP, NC is seeking an experienced Sr. Engineer to design, implement, and manage single-use manufacturing systems for cGMP Drug Product Manufacturing.

You will collaborate with Manufacturing, Process Sciences, Quality Assurance, and external vendors to ensure compliant operations and lifecycle management of equipment and facilities. Key responsibilities include equipment qualification (IQ/OQ/PQ), preventive maintenance, vendor coordination, and capital project

Qualifications

• Bachelor’s degree in Engineering (Mechanical/Chemical/Bioengineering) required.
• 10+ years in biotech/pharma/gene therapy space.
• Experience with single-use tech and viral vector manufacturing preferred.
• IQ/OQ/PQ and commissioning/qualification experience required.
• Knowledge of HVAC/utility systems and automation controls.

Responsibilities

• Support FUME team in engineering and automation standard development.
• Provide equipment/automation specifications, installation, start-up, IQ/OQ/PQ activities.
• Train staff on new equipment/operations as needed.
• Provide real-time manufacturing campaign support and troubleshoot issues.
• Maintain validated equipment state via preventive maintenance and calibration programs.
• Lead site engineering projects upgrading facilities, utilities, and automation systems.
• Oversee capital projects and site master plan for commercial readiness.
• Monitor building systems (HVAC, electrical, plumbing).
• Ensure compliance with cGMP, FDA/EU regulations and EHS guidelines.
• Create and maintain engineering documentation in collaboration with QA.

Skills

Facility engineering

GMP/CGMP

Single-use systems

Viral vector manufacturing

IQ/OQ/PQ

Automation controls

HVAC/Utilities

Cross-functional collaboration

Troubleshooting

Regulatory compliance

Project management

On-call support

Vendor coordination

Travel readiness

Education

Bachelor’s degree in Engineering (Mechanical/Chemical/Bioengineering)

Job description

Encoded Therapeutics Inc. in RTP, NC is seeking an experienced Sr. Engineer to design, implement, and manage single-use manufacturing systems for cGMP Drug Product Manufacturing.

You will collaborate with Manufacturing, Process Sciences, Quality Assurance, and external vendors to ensure compliant operations and lifecycle management of equipment and facilities. Key responsibilities include equipment qualification (IQ/OQ/PQ), preventive maintenance, vendor coordination, and capital project