Process Engineer III (Tech Transfer)

WaveCrest Staffing Group; Massachusetts; On-site; USD 110,000 - 140,000; Full time

Job summary

[Undisclosed Life Sciences Client] in Middlesex County, MA, seeks a Process Engineer III for a 2-6 month contract to lead tech transfer, process development, and qualification across sites.

The role requires GMP/ISO 9001 experience, strong project management, and ability to lead cross-functional teams with manufacturing, QA, and R&D involvement.

Qualifications

• Bachelor's degree in Chemical, Mechanical, Biomedical Engineering, or related field.
• 5–7+ years of engineering experience in pharmaceutical, biopharmaceutical, medical device, life sciences, or regulated manufacturing.
• Experience in GMP and/or ISO 9001 environments.
• Hands-on experience with process/equipment validation, qualification, and technology transfer.
• Strong knowledge of manufacturing processes, process controls, equipment design, and Lean principles.
• Experience with SPC, statistical analysis, and data-driven process improvement.
• Proven project management and cross-functional leadership experience.
• Strong technical problem-solving, communication, and organizational skills.
• Ability to manage multiple projects independently and provide technical direction to project teams.

Responsibilities

• Lead technology transfer, process stabilization, and implementation of new manufacturing processes across sites.
• Serve as SME for process development, TFF filtration, equipment design, qualification, and manufacturing operations.
• Lead process and equipment validation/qualification activities, including protocols, execution, and reports.
• Support new product introduction, process development, scale-up, and manufacturing implementation.
• Drive process improvements using SPC, data analysis, Lean Manufacturing, and continuous improvement methodologies.
• Develop engineering documentation, including protocols, change controls, action plans, and technical reports.
• Troubleshoot complex process and equipment issues and provide technical solutions to manufacturing operations.
• Lead multiple cross-functional engineering projects, managing schedules, risks, resources, and project deliverables.
• Collaborate with Manufacturing, Quality, Automation, R&D, and Engineering teams to achieve objectives.
• Provide technical leadership, mentoring, and guidance to junior engineers and project team members.
• Communicate project status, technical issues, risks, and recommendations to management and stakeholders.
• Support safety, quality, compliance, and continuous improvement initiatives.

Skills

Tech transfer

Process development

Cross-functional leadership

GMP ISO 9001

SPC analysis

Lean manufacturing

Project management

Troubleshooting

Education

Bachelor's degree in Chemical/Mechanical/Biomedical Engineering

Tools

SolidWorks

CAD

Electronic documentation systems

Job description

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 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!

Job type: 2-6 -month contract (possibility of extension or hire)

Location: Middlesex County, MA

Position Summary

The Process Engineer III will provide technical leadership and engineering support for technology transfer, multiproduct manufacturing, process development, equipment qualification, and project execution within a regulated life sciences manufacturing environment. The role will serve as a subject matter expert for manufacturing processes and equipment while supporting the implementation of new products, process improvements, and strategic engineering initiatives.

The ideal candidate will have experience in biopharmaceutical, pharmaceutical, medical device, or life sciences manufacturing, with a strong understanding of GMP or ISO 9001 environments, process controls, equipment design, validation, safety, and project management. The successful candidate will be highly collaborative, able to work independently, and comfortable leading cross-functional technical teams.

Responsibilities

• Lead technology transfer, process stabilization, and implementation of new manufacturing processes across sites.
• Serve as an SME for process development, TFF filtration, equipment design, qualification, and manufacturing operations.
• Lead process and equipment validation/qualification activities, including protocols, execution, and reports.
• Support new product introduction, process development, scale-up, and manufacturing implementation.
• Drive process improvements using SPC, data analysis, Lean Manufacturing, and continuous improvement methodologies.
• Develop engineering documentation, including protocols, change controls, action plans, and technical reports.
• Troubleshoot complex process and equipment issues and provide technical solutions to manufacturing operations.
• Lead multiple cross-functional engineering projects, managing schedules, risks, resources, and project deliverables.
• Collaborate with Manufacturing, Quality, Automation, R&D, and Engineering teams to achieve operational and project objectives.
• Provide technical leadership, mentoring, and guidance to junior engineers and project team members.
• Communicate project status, technical issues, risks, and recommendations to management and stakeholders.
• Support safety, quality, compliance, and continuous improvement initiatives.

Qualifications

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related discipline.
• 5–7+ years of engineering experience in pharmaceutical, biopharmaceutical, medical device, life sciences, or regulated manufacturing.
• Experience in GMP and/or ISO 9001 environments.
• Hands-on experience with process/equipment validation, qualification, and technology transfer.
• Strong knowledge of manufacturing processes, process controls, equipment design, and Lean principles.
• Experience with SPC, statistical analysis, and data-driven process improvement.
• Proven project management and cross-functional leadership experience.
• Strong technical problem-solving, communication, and organizational skills.
• Ability to manage multiple projects independently and provide technical direction to project teams.
• Experience with TFF, automation, microfluidics, mass spectrometry, or single-use systems is a plus.
• Proficiency with SolidWorks/CAD, Microsoft Office, and electronic documentation systems.