Job Specifications
Mechanical Automation Engineer
Location: Boston, MA or Rhode Island (Onsite 3 days/week)
Start Date: Mid–Late March
Duration: 12+ Months
Role Overview
Our client is seeking an experienced Mechanical Automation Engineer to lead the design and deployment of industrial machinery and automation systems in a GMP-regulated environment. This role spans the full lifecycle—from concept development through commercial-scale deployment—and requires deep expertise in mechanical design, automation, robotics, and single-use systems.
The engineer will work cross-functionally with controls, R&D, Manufacturing, and external vendors to deliver robust, scalable, and compliant automation solutions. This is a hands-on role that supports rapid development, validation, scale-up, and continuous improvement initiatives.
Key Responsibilities
Lead development of industrial machinery and automation systems from concept through commercial deployment.
Evaluate, select, and implement new equipment, technologies, and system modifications to support scale-up.
Perform mechanical design and integration of automation systems, including:
Robotics (Cartesian, SCARA, EOAT)
Single-use systems and cartridges
Conveyors, AGV/AMRs
Cam-followers and indexing mechanisms
Peristaltic pumps, pinch valves, solenoid valves, MFCs
Process Analytical Technologies (PAT)
Conduct detailed mechanical analyses, including:
Kinematic and dynamic analysis
Stress and tolerance stack-up analysis
Mechanism design
Cycle time and utilization calculations
Cam-follower design
Design equipment in compliance with aseptic, GMP, cleaning, and sterilization requirements.
Collaborate closely with controls engineers on integrated electro-mechanical designs.
Manage vendors through design reviews, FATs, and SATs.
Support validation, deviation management, CAPA, and change control activities.
Develop scale-up strategies from concept to commercial manufacturing.
Provide technical support to R&D and Manufacturing teams to ensure effective technology transfer.
Drive continuous improvement and equipment optimization initiatives.
Create and maintain equipment documentation, including:
3D CAD models
Mechanical drawings and layouts
Parts lists and assembly drawings
Generate drawings per ASME Y14.5M (GD&T) and apply relevant ANSI and ISO standards.
Statistically characterize equipment performance to ensure repeatability and robustness.
Provide hands-on troubleshooting support during development and manufacturing.
Execute project responsibilities on time and within budget, proactively communicating risks and delays.
Ensure compliance with all corporate, quality, and regulatory requirements.
Required Qualifications
BS or MS in Engineering or a related technical discipline.
5+ years of experience in automation development within a pharmaceutical, biotech, or other cGxP-regulated environment.
Strong experience with:
Robotics and automated machinery
Single-use system design
Custom mechanical components and mechanisms
Experience with cell and gene therapy manufacturing is highly desirable.
Proficiency with 3D CAD software, preferably SolidWorks.
Working knowledge of cGxP principles, with familiarity in ISO 13485, ISO 14971, and 21 CFR 820 considered a plus.
Strong understanding of statistical methods applied to equipment performance.
Proven ability to troubleshoot industrial automation systems.
Excellent technical writing, presentation, and communication skills.
Ability to work independently, manage multiple projects, and operate with a strong sense of urgency.
Demonstrated collaboration, interpersonal, and stakeholder management skills.
Work Arrangement
Full-time role, 5 days/week
Minimum 3 days onsite per week at Boston, MA and Rhode Island locations