Senior Mechanical Design Engineer (Evergreen Contract)

Job Description

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Senior Mechanical Design Engineer

Reporting to the Associate Director of Automating Equipment & Processes, this role will implement industrial automation for a range of medicinal modalities, including cell and gene therapy. The successful candidate will join the Automating Equipment & Processes Group to work on automation development, commissioning, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. This role will focus on machine and robotic design.

 

 

Key Responsibilities:

• Development of industrial automation used for production of medicinal modalities, including cell and gene therapy.
• Manage the evaluation and selection of new equipment/technologies or modifications to existing systems required for scale up.
• Machinery design and machinery design vendor management, including, but not limited to: kinematic design & analysis, dynamic analysis, stress analysis, tolerance stack analysis, mechanism design, cam-follower design, servo system design, robotic design, robotic end effector design, and stacker/de-stacker.
• Aseptic and GMP design.  Design for cleanability and compatibility with cleaning agents.  Single Use Set Design experience.
• Interface and collaborate with controls resources for joint electro-mechanical designs.
• 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.
• Executes and documents equipment commissioning activities including Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Supports equipment and process validation activities (IQ, OQ, PQ).
• Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
• Statistically characterizes equipment performance and implements designs to ensure repeatability and consistency.
• Design and manage vendor design of 3D CAD models and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.
• Create Equipment layouts in AutoCAD and/or Revit.
• Perform tolerance stack up calculations, GD&T, and 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 validating manufacturing equipment and processes is required. Knowledge and experience in utilizing risk-based approaches to validation process development and validation are highly advantageous.

• Understanding of cGxP principles and practices and familiarization with ISO 13485, ISO 14971, and 21CFR820 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.
• Hands-on approach to problem solving, risk identification and resolution. Six-sigma Green Belt / DMAIC problem solving experience preferred.
• 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 is