What are the responsibilities and job description for the Automation PLC Engineer position at Innovative Consulting Inc (ICI)?
About ICI
Innovative Consulting Inc. is a global software and engineering consulting firm providing professional services in: Automation, Manufacturing Execution Systems (MES), and Smart Manufacturing. With combined 20 years of experience in cGMP and FDA regulated industries, our growing and dedicated team of engineers continue to deliver innovative automation related solutions and expertise to plan, design, implement, and maintain projects in alignment with industry standards. We provide professional support and companionship for consulting services, project governance, and accelerating customer solutions in Automation, Manufacturing Systems & Information Technology. We provide client services that include Automation & IT Strategy, Concept Design, Project Execution, Service & Support, Life Cycle Planning & Optimization Services.
Role and Responsibilities
This role will be responsible for supporting the design, installation, and validation for the sterile purification and recycling isolators into commercial production. This role will be a project team member in the Site ITOT team and will support the Automation activities of a validation team on a second shift. The role will start initially on day shift moving to a second shift which for an extended period may require 9-10 hours per day 6 days per week during the critical validation period as the equipment completes IOPQ activities
Skills and Qualifications
- Bachelor’s degree in engineering or related field with 7 years of relevant engineering experience in the Pharmaceutical or Chemical industry
- Hands-on experience in configuring and troubleshooting PLC & HMI systems (Rockwell, Siemens).
- Solid understanding of Computer System Validation (CSV) for qualifying automation systems.
- In-depth knowledge of FDA regulations, including 21 CFR Part 11 and GMP systems.
- Experience in pharmaceutical GMP manufacturing operations, including aseptic fill/finish and/or radio pharmacy, is preferred.
- Strong communication skills with the ability to collaborate effectively across cross-functional teams.
- Experience in stakeholder management and building productive relationships at all levels of the organization.
- Strong project management skills, including planning, execution, and delivery of automation projects.