What are the responsibilities and job description for the Automation Control Engineer position at Katalyst HealthCares & Life Sciences?
Job Summary:
We are seeking a highly skilled Automation & Validation Engineer to support equipment design, validation, and automation in a medical device manufacturing environment. The ideal candidate will have experience in automation control systems, validation (IQ, OQ, PQ, TMVs), and equipment troubleshooting. This role involves working closely with external suppliers, supporting design reviews, and ensuring compliance with industry standards.
- Support design reviews, debugging, acceptance, and validation of equipment developed by external suppliers.
- Assist in decommissioning and recommissioning of equipment to ensure proper functionality and compliance.
- Conduct and analyze Gauge Repeatability & Reproducibility (GR&R) studies and Process Capability assessments.
- Work with automation control systems, including PLCs, HMIs, Vision Systems, Servos, and Robots.
- Develop and optimize programs for Allen-Bradley/Rockwell Automation (Studio5000, RSView ME/SE) and Siemens S7.
- Provide hands-on support for Staubli, EPSON, and ABB robotics integration and programming.
- Execute and document validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and TMVs (Test Method Validations).
- Ensure compliance with FDA, ISO 13485, and GMP requirements for medical device manufacturing.
- Collaborate with cross-functional teams, including Manufacturing, Quality, and R&D, to improve equipment performance and reliability.
- 4 years of experience in a medical device manufacturing environment.
- Strong preference for assembly automation systems experience.
- Background in automation control systems, including PLCs, HMIs, vision systems, servos, and robotics.
- Hands-on experience with Allen-Bradley/Rockwell Automation, Siemens S7, Staubli, EPSON, or ABB robotics.
- Experience in statistical analysis techniques, specifically GR&R and process capability assessments.
- Strong knowledge of validation protocols (IQ, OQ, PQ, TMVs).
- Familiarity with Good Manufacturing Practices (GMP), FDA regulations, and ISO 13485 standards.
- Excellent problem-solving skills, analytical thinking, and attention to detail.
- Strong communication and collaboration skills to work effectively in a cross-functional environment.
- Experience with medical device automation and validation projects.
- Knowledge of robotic programming and industrial automation best practices.
- Six Sigma or Lean Manufacturing certification is a plus.
