Process Engineer III

Location:

Middlesex County, MA

Pay Rate Low: 80 | Pay Rate High: 100
$80 - $100/hr doe

6‑month contract (possibility of extension or hire)

Experienced 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.

• 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.

• 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 Solid Works/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.