Senior Manufacturing Engineer

At Terrestrial Bio, Manufacturing Engineering is not a support function. It is the technical foundation that

transforms innovative product concepts into robust, compliant, and scalable manufacturing operations. The

decisions made today will determine our ability to successfully transition from clinical manufacturing to

commercial production while maintaining product quality, regulatory compliance, and operational

We are building our manufacturing organization from the ground up. We need a highly experienced

engineer who can independently lead complex technical initiatives, establish engineering best practices,

The Senior Manufacturing Engineer III is a senior technical leader responsible for implementing and

optimizing the manufacturing systems that will support Terrestrial Bio’s next phase of growth. This role will

lead equipment integration, process validation, technology transfer, and continuous improvement

initiatives while helping establish the engineering standards, documentation, and manufacturing processes

This is not simply a production support role. It is a build role with significant technical ownership. The

successful candidate will help design the manufacturing systems, engineering processes, and operational

infrastructure that enable Terrestrial Bio to scale efficiently while maintaining compliance, product quality,

You will establish the Manufacturing Engineering function from the ground up and play a critical role in

Lead technical implementation and integration of highly automated equipment and processes,

including commissioning, qualification (IQ/OQ/PQ), technology transfer, and site expansion/startup

Develop manufacturing engineering standards, SOPs, equipment lifecycle documentation, and

Establish cross-functional partnerships with Automation, Quality, Facilities, Process Development,

and Manufacturing Operations; lead investigations, change controls, CAPAs, root cause analyses, and

Serve as a senior technical resource and mentor, collaborate with suppliers on FAT/SAT and

The Senior Manufacturing Engineer III is responsible for providing technical leadership and execution for

manufacturing engineering activities supporting Phase 3 commercial manufacturing of a highly automated

pharmaceutical-medical device combination product manufactured in ISO Class 5 isolator environments

Experience with transfer, installation, startup, and integration of highly automated manufacturing

Experience operating within Grade A/ISO Class 5 or aseptic/low bioburden manufacturing

Develop and execute qualification protocols including Installation Qualification (IQ), Operational

Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment, facilities,

Develop, review, and revise manufacturing engineering documentation including protocols,

reports, work instructions, standard operating procedures (SOPs), engineering specifications, and

Participate in cross-functional capital projects including equipment selection, vendor management,

User Requirements (URS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT),

Support implementation and lifecycle management of Manufacturing Execution Systems (MES),

Provide technical support for deviation investigations, nonconformances, CAPAs, change controls,

Apply engineering principles and statistical methods to improve equipment reliability, process

Identify and implement continuous improvement initiatives to improve manufacturing robustness,

Support scale-up activities from clinical manufacturing through commercial readiness while

Evaluate manufacturing risks and recommend mitigation strategies utilizing Quality Risk

Mentor junior manufacturing engineers and engineering technicians by providing technical

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering,

Minimum 6+ years of manufacturing engineering experience in pharmaceutical, biotechnology,

Demonstrated experience supporting Phase 2 and/or Phase 3 clinical manufacturing environments

Demonstrated experience independently leading cross-functional technical projects.

Strong understanding of cGMP regulations and for pharmaceutical and/or combination product

Excellent analytical, troubleshooting, and structure problem-solving skills.

Effective written and verbal communication skills with the ability to influence cross-functional

Experience supporting drug-device combination product manufacturing.

Experience with isolator-based manufacturing systems and/or aseptic processes.

Knowledge of 21 CFR Parts, 210, 211, 820, and Part 11 requirements.

Strong understanding of validation lifecycle management and risk-based qualification strategies.

Experience supporting implementation of Manufacturing Execution Systems (MES) and Electronic

Lean Six Sigma Green Belt or Black Belt certification

Experience supporting technology transfer from development through commercial manufacturing.

Highly automated ma