Process Engineer III (CONTRACT - Until 12/31)

Connexion Systems + Engineering; Sudbury (MA); On-site; USD 110,000 - 138,000; Full time

Job summary

Connexion Systems & Engineering Inc. in Sudbury, MA is seeking a Process Engineer III for a contract role (through 12/31) on site.

The role focuses on tech transfer of consumable products, process stabilization, and leading cross-functional projects with emphasis on quality and efficiency. Ideal candidates bring 5–7 years in life sciences or related fields, a bachelor’s in engineering, and hands-on experience with data analysis, design/qualification, and lean manufacturing principles.

Qualifications

• Typically requires 5–7 years of experience in a life science, pharmaceutical, medical device, or biologics setting.
• Bachelor's degree in engineering is required; strong technical proficiency and cross-functional collaboration are expected.

Responsibilities

• Serve as SME for tech transfer of consumable product and stabilization of manufacturing process.
• Provide leadership in filtration, equipment design/qualification, tech transfer, and project management.
• Communicate with a global engineering network to advance strategic project initiatives.
• Identify and drive continuous improvement, regulatory compliance, and efficiency.
• Generate engineering documentation including test protocols, change controls, and reports.
• Support new product implementations and process design during development.
• Mentor junior staff and establish standards and training for best practices.
• Apply statistical methods to support engineering tests and process validations.
• Lead process improvements for best-in-class manufacturing.

Skills

Tech Transfer

Project management

Statistical methods

Lean principles

Independent problem solving

Team leadership

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

SolidWorks/CAD

MS Office

Electronic file management

Job description

Process Engineer III (CONTRACT - Until 12/31) Location: Sudbury, MA Pay Rate: 80 - 100/hr JOB DESCRIPTION Essential Duties and Responsibilities:

• Serve as a Subject Matter Expert (SME) for Tech Transfer of consumable product and stabilization of manufacturing process.
• Provide leadership and coaching in the areas of TFF filtration, equipment design and qualification, tech transfer, project management, and facility design.
• Communicate with a global engineering network to advance strategic project initiatives in support of ongoing corporate growth.
• Identify and drive continuous improvement efforts, industry standards, regulatory compliance, and efficiency.
• Generate engineering documentation including test protocols, change controls, action plans, and reports.
• Support the implementation of new products and associated manufacturing processes. Contribute to the process design for new products during the development phase
• Provide mentoring to junior staff members and support for establishing standards and training for best practices in process development.
• Utilize statistical methods to support engineering tests and process validations.
• Perform research and implementation of process improvements to support best in class manufacturing

This is an on-site role.

Initial travel requirements are <25%, long term travel is <10%.

Education and/or Work Experience:

Typically requires 5-7 years’ experience in a life science, pharmaceutical, medical device, and/or biologics setting required. Bachelor's degrees in engineering discipline Knowledge: Consistent technical proficiency, and collaboration with others. Broad expertise or unique knowledge, use skills to contribute to development of company principles and to achieve goals. Complexity: Conceives, plans, and executes projects or aspects of projects related to the strategic needs of the company. Applies advanced technical knowledge to multi-disciplinary projects. Independent management of multiple projects.

Target: 40% Plant Support, 60% Projects Supervision: Can execute projects with minimal direction on projects goals and work with significant autonomy Can independently generate projects definition. May inform the definition to the manager Ability to communicate issue and project status to local management team Delegates work with manager to more junior staff Teamwork: Provides technical direction and feedback. Capable of leading the technical team on a project. Will lead their work independently or lead an entire team or subsection of a project / cross functional team.

• Process and Equipment Validation/Qualification
• Technology transfer between manufacturing sites
• Experience working with cross-functional groups and managing projects through a matrix of resources to complete
• Statistical Process Control, Data Analysis
• Microfluidics
• Mass Spectrometry
• Chemical vapor disposition
• Tangential Flow Filtration
• Technology transfer between manufacturing sites
• Automation
• Ability to think outside the box
• Independent problem solving and the ability to drive a team to support an ongoing ISO-9001 regulated operation.
• Thorough understanding of lean principles and manufacturing processes is required.
• Working knowledge of single-use products and sterilization processes is desired.
• Biopharmaceutical and/or Medical Device development experience is desired.
• Must lead by example and possess a high sense of personal integrity and accountability.
• Must possess high bandwidth and be able to fill multiple roles, as needed.
• Must be proficient with SolidWorks/CAD, MS Office, and electronic file management.

Physical Requirements:

• Regularly work in a clean room and laboratory environment.
• Regularly exposed to chemicals, fumes and/or airborne particles.
• Regularly exposed to moving mechanical parts, vibration, and noise.
• Occasionally exposed to risk of electrical shock.
• Occasionally lift and/or move up to 50 pounds.