Tech Transfer/ Process Engineer III

Astrix Inc.; Marlborough (MA); On-site; USD 110,208 - 137,760; Full time

Job summary

Astrix Inc. in Marlborough, MA is seeking a skilled Tech Transfer/Process Engineer III to lead technology transfer and manufacturing process support within a GMP/ISO 9001 environment.

You will guide process development, equipment qualification, validation, and scale-up for new product introductions, collaborating with global engineering teams to drive efficiency and compliance. The ideal candidate has 5–7 years in biopharma or life sciences manufacturing, hands-on GMP/ISO experience, and strong

Qualifications

• Bachelor's degree in Engineering or related field.
• 5–7 years of engineering experience in biopharma/manufacturing.
• GMP/ISO 9001 experience with process engineering, tech transfer, equipment qualification, and validation.
• Strong knowledge of Tangential Flow Filtration (TFF) and SPC.
• Proficiency with SolidWorks/CAD, Microsoft Office, and documentation systems.
• Proven ability to lead multiple projects and cross-functional teams.

Responsibilities

• Lead technology transfer activities and support manufacturing process stabilization across multiple products and sites.
• Manage engineering projects and provide technical support for day-to-day manufacturing operations in a regulated environment.
• Develop and execute IQ/OQ/PQ protocols and support process validation.
• Prepare engineering change controls, test protocols, validation reports, risk assessments, and technical documentation.
• Drive continuous improvement using Lean, SPC, and data analysis to improve process efficiency, quality, and compliance.
• Support new product introductions from design to scale-up and manufacturing implementation.
• Collaborate with cross-functional teams to execute strategic projects and resolve technical issues.
• Mentor junior engineers and promote engineering best practices and standardization.
• Identify and implement process improvements while ensuring GMP/ISO:9001 compliance.

Skills

GMP knowledge

SPC

Process optimization

Project management

Analytical skills

Education

Bachelor's degree in Engineering

Tools

SolidWorks/CAD

Microsoft Office

Documentation systems

Job description

Pay Rate Low: 80 | Pay Rate High: 100 Our client is a leading life sciences company that develops and manufactures tools and materials used in the production of biologic drugs. They are looking for a skilled Tech Transfer/Process Engineer III to join their growing team in Middlesex County, MA! This is a great opportunity to contribute to an innovative life science organization! Location: Middlesex County, MA Pay rate: $80 - $100/hr. DOE Job type: 6-month contract (possibility of extension or hire)

Position Summary

Experienced Tech Transfer/Process Engineer III responsible for leading technology transfer, manufacturing process support, and strategic engineering projects within a GMP/ISO 9001 regulated environment. Provides technical leadership for process development, equipment qualification, process validation, and manufacturing optimization while supporting new product introductions and continuous improvement initiatives. Collaborates with cross-functional and global engineering teams to ensure efficient, compliant, and reliable manufacturing operations.

Key Responsibilities

• Lead technology transfer activities and support manufacturing process stabilization across multiple products and manufacturing sites.
• Manage engineering projects while providing technical support for day-to-day manufacturing operations in a regulated environment.
• Develop and execute process and equipment qualification/validation (IQ/OQ/PQ) protocols and support process validation activities.
• Prepare engineering documentation, including change controls, test protocols, validation reports, risk assessments, and technical documentation.
• Drive continuous improvement initiatives by applying Lean manufacturing principles, statistical process control (SPC), and data analysis to improve process efficiency, quality, and compliance.
• Support new product introductions by contributing to process design, scale-up, and manufacturing implementation.
• Collaborate with cross-functional teams, including Manufacturing, Quality, R&D, Validation, and Global Engineering, to execute strategic projects and resolve technical issues.
• Mentor junior engineers, provide technical guidance, and promote engineering best practices and standardization.
• Identify and implement process improvements while ensuring compliance with GMP, ISO 9001, and company quality standards.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 5–7 years of engineering experience in biopharmaceutical, pharmaceutical, biologics, medical device, or other life sciences manufacturing environments.
• Hands‑on experience in GMP and/or ISO 9001 regulated manufacturing with knowledge of process engineering, technology transfer, equipment qualification, and process validation.
• Strong technical expertise in Tangential Flow Filtration (TFF), Statistical Process Control (SPC), automation, Lean manufacturing, process optimization, and data analysis.
• Proficiency with SolidWorks/CAD, Microsoft Office, and engineering documentation systems.
• Demonstrated success managing multiple engineering projects, leading cross‑functional teams, and solving complex manufacturing challenges with minimal supervision.
• Excellent communication, project management, and analytical skills with a commitment to continuous improvement, quality, and operational excellence.

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