Automation Engineer --W2

United Pharma; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading pharmaceutical company is seeking an experienced Mechanical Automation Engineer to lead the design and deployment of automation systems in a GMP-regulated environment. The ideal candidate will have over 5 years of experience in automation development within biotech, alongside proficiency in 3D CAD software like SolidWorks. This hands-on role requires strong technical skills, collaboration with cross-functional teams, and a focus on continuous improvement while ensuring compliance with quality standards.

Qualifications

• 5+ years of experience in automation development within a pharmaceutical or cGxP-regulated environment.
• Proficiency with 3D CAD software, preferably SolidWorks.
• Strong ability to troubleshoot industrial automation systems.

Responsibilities

• Lead development of industrial machinery from concept to commercial deployment.
• Evaluate and implement new equipment to support scale-up.
• Conduct detailed mechanical analyses and design compliance with GMP.

Skills

Automation development

Mechanical design

Robotics

3D CAD software

Statistical methods

Education

BS or MS in Engineering

Tools

SolidWorks

Job description

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:
• 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.

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
• 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.