Atrium ยท 6 hours ago
Senior Mechanical & Automation Engineer
Boston, MA
Contract
Hybrid
Senior Level
$75/hr - $90/hr
5+ years expAtrium is seeking a Senior Mechanical & Automation Engineer to revolutionize Cell & Gene Therapy by developing cutting-edge manufacturing solutions. The role involves automating complex processes in biotechnology and requires expertise in mechanical engineering and automation to streamline manufacturing and enhance reliability.
Real Estate
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
Qualification
Required
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
Company
Atrium
Atrium is a global WBENC-certified Talent Solutions and Extended Workforce Management leader.
201-500 employees
H1B Sponsorship
Atrium has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Caylon Joiner
Talent Acquisition Partner
Shannon Mooney
Managing Director, Strategic Partnerships
Company data provided by crunchbase