Senior Biotech Manufacturing Engineer - cGMP & Single-Use

Encoded Therapeutics; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Stock options

PTO & holidays

Parental leave

Pre-tax benefits

Wellness program

Job summary

Encoded Therapeutics Inc. is seeking a Sr. Engineer to join our facilities team in RTP, NC. You will design, implement and manage single-use manufacturing systems and supporting infrastructure to enable cGMP Drug Product Manufacturing.

You will collaborate with Manufacturing, Process Sciences, Supply Chain and Quality Assurance, lead engineering projects, ensure equipment validation (IQ/OQ/PQ), preventive maintenance, and compliance with regulatory requirements.

Qualifications

• Bachelor's degree in Engineering required.
• 10+ years of biotech/pharma or gene therapy experience.
• Experience with single-use technology and viral vector manufacturing.
• Knowledge of cGMP systems and regulatory requirements.

Responsibilities

• Develop and apply engineering standards and procedures.
• Provide technical support for equipment and automation required for GMP manufacturing.
• Lead site engineering projects including upgrades of facility, utility, and automation systems.
• Manage capital projects and site master plan for design/build for commercial manufacturing.
• Perform or oversee building systems monitoring (HVAC, electrical, plumbing, utilities).
• Follow EHS guidelines to ensure compliant operations and regulatory adherence.
• Coordinate with Quality Assurance for SOPs, change controls, and CGEP documentation.
• Maintain documentation and records related to site engineering and facilities management.

Skills

Single-use technology

GMP manufacturing

Facilities engineering

Cross-functional collaboration

Equipment qualification

Troubleshooting

Education

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

Job description

Encoded Therapeutics Inc. is seeking a Sr. Engineer to join our facilities team in RTP, NC. You will design, implement and manage single-use manufacturing systems and supporting infrastructure to enable cGMP Drug Product Manufacturing.

You will collaborate with Manufacturing, Process Sciences, Supply Chain and Quality Assurance, lead engineering projects, ensure equipment validation (IQ/OQ/PQ), preventive maintenance, and compliance with regulatory requirements.