Senior Manufacturing Engineer

Terrestrial Bio•Woburn, MA

8d•$120,000 - $140,000•Onsite

About The Position

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration. 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 excellence. 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, and serve as a technical authority across manufacturing, validation, automation, and quality. 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 that will support a highly automated manufacturing operation. 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, and operational agility.

Requirements

Bachelor's degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Industrial Engineering, or related engineering discipline.
Minimum 6+ years of manufacturing engineering experience in pharmaceutical, biotechnology, medical device, or combination product manufacturing.
Demonstrated experience supporting Phase 2 and/or Phase 3 clinical manufacturing environments with combination products, polymer processing, and/or unique drug delivery technologies.
Demonstrated experience independently leading cross-functional technical projects.
Strong understanding of cGMP regulations and for pharmaceutical and/or combination product quality systems.
Excellent analytical, troubleshooting, and structure problem-solving skills.
Effective written and verbal communication skills with the ability to influence cross-functional teams.
Experience with transfer, installation, startup, and integration of highly automated manufacturing systems, including custom automation and OEM equipment.
Experience operating within Grade A/ISO Class 5 or aseptic/low bioburden manufacturing environments.
Develop and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment, facilities, utilities, and ancillary systems.
Develop, review, and revise manufacturing engineering documentation including protocols, reports, work instructions, standard operating procedures (SOPs), engineering specifications, and equipment lifecycle documentation.
Participate in cross-functional capital projects including equipment selection, vendor management, User Requirements (URS), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), qualification protocols, validation reports, commissioning, and startup activities.

Nice To Haves

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 Batch Records (EBR).
Lean Six Sigma Green Belt or Black Belt certification.
Experience supporting technology transfer from development through commercial manufacturing.

Responsibilities

Lead technical implementation and integration of highly automated equipment and processes, including commissioning, qualification (IQ/OQ/PQ), technology transfer, and site expansion/startup activities.
Develop manufacturing engineering standards, SOPs, equipment lifecycle documentation, and validation documentation to support a robust, compliant, and scalable operation.
Establish cross-functional partnerships with Automation, Quality, Facilities, Process Development, and Manufacturing Operations; lead investigations, change controls, CAPAs, root cause analyses, and continuous improvement initiatives to improve reliability, yield, throughput, and OEE.
Serve as a senior technical resource and mentor, collaborate with suppliers on FAT/SAT and startup, and support regulatory activities.
Provide 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.
Support implementation and lifecycle management of Manufacturing Execution Systems (MES), Electronic Batch Records (EBR), and equipment data acquisition systems.
Provide technical support for deviation investigations, nonconformances, CAPAs, change controls, and equipment troubleshooting using structured root cause analysis methodologies.
Apply engineering principles and statistical methods to improve equipment reliability, process capability, throughput, yield, and Overall Equipment Effectiveness (OEE).
Identify and implement continuous improvement initiatives to improve manufacturing robustness, efficiency, and product quality.
Support scale-up activities from clinical manufacturing through commercial readiness while ensuring phase-appropriate GMP compliance.
Evaluate manufacturing risks and recommend mitigation strategies utilizing Quality Risk Management principles.
Mentor junior manufacturing engineers and engineering technicians by providing technical guidance, knowledge sharing, and project leadership.