We are seeking motivated and experienced process engineer 3 who will focus on tech transfer, multiproduct manufacturing support, and project execution at the Marlborough, 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 5-8 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.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $115,000-$150,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
