Senior Mechanical & Automation Engineer

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Senior Mechanical & Automation Engineer
Job Location: Boston MA
Job Duration: 06 Months

Are you ready to revolutionize Cell & Gene Therapy Join us in shaping the future of therapeutics! We are seeking a Senior Mechanical & Automation Engineer in our journey of developing cutting-edge manufacturing solutions for Casgevy-a first-of-its-kind therapy transforming the treatment of Sick Cell Disease and Beta 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 whats 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 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.
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.

Job Title: Senior Mechanical & Automation Engineer Job Location: Boston MA Job Duration: 06 Months Are you ready to revolutionize Cell & Gene Therapy Join us in shaping the future of therapeutics! We are seeking a Senior Mechanical & Automation Engineer in our journey of developing cutting-edge ...

Job Title: Senior Mechanical & Automation Engineer
Job Location: Boston MA
Job Duration: 06 Months

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 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.
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.