Automation Engineer --W2

Duration: 12+ Months

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.

• 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:
• Single‑use systems and cartridges
• 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
• Cycle time and utilization calculations
• 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:
• 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.

• 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
• Custom mechanical components and mechanisms
• Experience with cell and gene therapy manufacturing is highly desirable.
• Proficiency with 3D CAD software
  , preferably Solid Works
  .
• 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.