Automation Engineer

Innovative Consulting Inc (ICI); Indianapolis (IN); On-site; USD 85,000 - 159,000; Full time

Job summary

An established industry player is seeking an Automation Engineer to support the design and validation of sterile purification systems. This role involves hands-on experience with PLC and HMI systems, ensuring compliance with FDA regulations, and managing automation projects. The ideal candidate will have a strong background in engineering, excellent communication skills, and a proven track record in stakeholder management. Join a dedicated team that thrives on innovation and collaboration in the pharmaceutical manufacturing sector, where your expertise will contribute to the success of critical projects.

Qualifications

• 7+ years of experience in the Pharmaceutical or Chemical industry.
• Hands-on experience with PLC & HMI systems (Rockwell, Siemens).
• Strong project management skills and stakeholder management.

Responsibilities

• Support design, installation, and validation for sterile purification systems.
• Collaborate with the validation team on automation activities.
• Manage project timelines during critical validation periods.

Skills

Engineering

PLC & HMI Configuration

Computer System Validation

FDA Regulations

Project Management

Communication Skills

Stakeholder Management

Education

Bachelor’s degree in Engineering

Job description

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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