Senior Process Engineer
- 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.
- Typically requires 5-8 years’ experience in a life science, pharmaceutical, medical device, and/or biologics setting required.
- Bachelor's degrees in engineering discipline
- 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.
- 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
- 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
- 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.
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