Senior Mechanical & Automation Engineer

Job Title:
Senior Mechanical & Automation Engineer

Job Location:

Boston, MA
Job Duration: 06 Months

In this role, you will be at the forefront of automating complex processes in one of the most dynamic and rapidly evolving fields in biotechnology. By leveraging your expertise in mechanical engineering and automation, you will play a pivotal role in streamlining manufacturing, enhancing manufacturing reliability, and scaling life-saving therapies to reach patients faster. You will work with a passionate team of scientists, engineers, and innovators, all united by a shared mission: to push the boundaries of what's possible in Cell & Gene Therapy.

This role reports to the Associate Director of Automation, Equipment, and Processes.

Key Responsibilities:

• Development of industrial machinery and automation from concept through commercial deployment.
• Manage the evaluation and selection of new equipment/technologies or modifications to existing systems required for scale up.
• Mechanical Design and integration, including, but not limited to robotics, single-use sets, single-use set cartridges, conveyors, AGV/AMRs, cam-followers, peristaltic pumps, pinch valves, MFCs, Solenoid valves, and process analytical technologies, and more.
• Mechanical Design Analysis, including, but not limited to kinematic design & analysis, dynamic analysis, stress analysis, tolerance stack analysis, mechanism design, cycle time calculation, utilization calculations, and cam-follower design.
• Aseptic and GMP design. Design for compatibility with cleaning and sterilization. Single Use Set Design experience.
• Interface and collaborate with controls resources for joint electro-mechanical designs.
• Manage vendors and perform design reviews, FATs, and SATs. Support validation activities.
• Create a scale up plan from concept through commercial equipment deployment.
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Support optimization and improvement in equipment/systems/processes.
• Establishes equipment documentation, including parts lists, mechanical drawings, and assembly drawings. Provides engineering change documentation as appropriate.
• Statistically characterizes equipment performance and implements designs to ensure repeatability and consistency.
• Design and manage vendor design of 3D CAD models. Collaborate with vendors to produce prototype and production parts.
• Create Equipment layouts in AutoCAD and/or Revit.
• Create drawings to ASME Y14.5M-200977. Understand and apply other respective standards within machine design, including ANSI and ISO standards.
• Provide hands-on troubleshooting, equipment, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.
• Execute assigned duties on time and within budget; proactively communicate delays and other issues to relevant stakeholders.
• Comply with all regulatory, corporate, and Quality System policies. Support Deviation Management, CAPA, and Change Control activities, as required.
• Performs other duties as assigned.

Required Qualifications:

• BS or MS in engineering or another relevant discipline.
• 5+ years of experience working within an automation development environment (pharmaceutical, cGxP preferred). Experience with cell & gene therapy is highly desirable.
• Experience working with a variety of automation hardware, including but not limited to, custom-fabricated mechanical components, cam systems, linkages, index and dwell machines, cartesian robots, SCARA robots, end of arm tooling, and dip coating.
• Experience developing single use sets.
• Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21
  
  CFR
  820 is a plus. Knowledge of global cGMP requirements governing device or combination products.
• Experience with 3D CAD software, preferably with Solidworks.
• Experience troubleshooting industrial automation.
• A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
• Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
• Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
• Must demonstrate strong interpersonal, presentation, and teamwork skills.
• This is a 5 days a week role, requiring 3 days onsite per week at our Boston and Rhode Island offices.