| Location | NULL, MA |
| Salary | $77–$82 |
Location: Marlborough, MA (Onsite)
Employment Type: Contract
Duration: 8 Months
Job Responsibilities
Serve as a Subject Matter Expert (SME) for technology transfer of consumable products and manufacturing process stabilization.
Provide technical leadership in Tangential Flow Filtration (TFF), equipment design and qualification, technology transfer, project management, and facility design.
Coordinate with global engineering teams to support strategic project initiatives and manufacturing improvements.
Drive continuous improvement initiatives, regulatory compliance, operational efficiency, and industry best practices.
Develop engineering documentation, including test protocols, change controls, action plans, and technical reports.
Support new product implementation and contribute to manufacturing process design during product development.
Provide technical guidance and mentoring to junior engineers and support process development standards and training.
Apply statistical methods to engineering tests and process validation activities.
Lead process improvement initiatives to enhance manufacturing performance.
Manage multiple projects independently while coordinating cross-functional engineering and manufacturing resources.
Provide technical direction, communicate project status, and support site manufacturing operations.
Support process and equipment qualification, technology transfer between manufacturing sites, and ongoing plant operations.
Bachelor's degree in Engineering is required.
5 7 years of experience in life sciences, pharmaceutical, medical device, or biologics manufacturing.
Experience in GMP or ISO 9001-regulated manufacturing environments.
Hands-on experience with technology transfer and manufacturing process stabilization.
Strong knowledge of Tangential Flow Filtration (TFF), process engineering, and equipment design.
Experience with process and equipment validation/qualification.
Knowledge of statistical process control, data analysis, and lean manufacturing principles.
Experience managing cross-functional projects and working with global engineering teams.
Ability to independently manage projects, troubleshoot issues, and provide technical leadership.
Proficiency in SolidWorks/CAD, Microsoft Office, and electronic document management.
Strong communication, collaboration, and problem-solving skills.
Experience with microfluidics, mass spectrometry, and chemical vapor deposition.
Knowledge of automation, single-use products, and sterilization processes.
Biopharmaceutical or medical device product development experience.
Experience with process improvement and manufacturing scale-up.
Ability to mentor junior engineers and lead technical project teams.
Anticipated hourly pay range: $77/hr to $82/hr on W2.
BenefitsEmployees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.