Process Engineer

• SME for tech transfer, TFF filtration, equipment qualification, and process stabilization.
• Leads cross-functional projects with significant autonomy; manages both plant support (40%) and project work (60%).
• Generates engineering documentation (protocols, change controls, reports) and supports new product/process implementation.
• Mentors junior engineers and drives continuous improvement, compliance, and lean manufacturing.
• Requires 5 - 7 years in life sciences/pharma/biologics and a bachelor’s degree in engineering.
• Strong experience in process validation, tech transfer, data analysis, automation, and ISO-9001 environments.

JOB DESCRIPTION

Essential Duties and Responsibilities:

We are seeking motivated and experienced Contract, Process Engineer III who will focus on tech transfer, multiproduct manufacturing support, and project execution at the Sudbury, MA facility. They will provide technical leadership to the site and work to deliver projects alongside the global engineering network. The candidate will have work experience with bio/pharma manufacturing systems, process control, change management, equipment design, safety, and qualification activities. The ideal candidate should have relevant experience in a GMP or ISO9001 manufacturing environment and thrive in an agile and collaborative culture. A team player with strong communication skills will succeed in this role.

·       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

Expertise:

·       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.