Senior Mechanical Design Engineer (Evergreen Contract)

Join Our Talent Pool - Were always looking for great talent! Apply now to join our talent pool for upcoming Mechanical Design Engeeing opportunities.

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 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 issues to involved stakeholders and management.
• Must demonstrate strong interpersonal presentation and teamwork skills.
• Role will require 3 days onsite between our Boston and Providence sites.

**this is not a current opening but rather a talent pipeline for you to apply to future openings.

TBD

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements

By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .

If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.

No C2C or Third-Party Vendors