Automation Engineer (Manufacturing)
- Provide technical support for automation systems and equipment related to optimization strategies, system upgrades, replacements, and modifications.
- Ensure compliance with corporate policies, regulatory guidelines, and FDA standards (e.g., 21 CFR Part 11, 210/211).
- Apply and enforce automation engineering best practices, including GAMP 5 and GxP principles.
- Collaborate with cross-functional teams to develop and implement automation strategies.
- Prepare and execute project deliverables, ensuring adherence to schedules and quality standards.
- Serve as the main technical liaison for project stakeholders and report progress to the Project Manager.
- Coordinate with internal and client approvers to prevent delays and ensure alignment with project timelines.
- Participate in technical and project meetings as required.
- Develop, review, and execute documentation including URS, FRS, DDS, FAT, SAT, IQ, OQ, and PQ.
- Support Installation, Characterization, Commissioning, and Qualification (C&Q) activities.
- Maintain open and effective communication with client project teams and stakeholders.
- Bachelor’s degree in Engineering or Science, preferably in Computer Science, Computer Engineering, or Electrical Engineering.
- Minimum 5 years of experience in automation engineering or related field, preferably in a regulated pharmaceutical or biotechnology environment.
- Strong technical expertise with PLC and SCADA systems, including integration with robots and machine vision platforms.
- Hands-on experience with:
- Rockwell Automation and Siemens HMIs and PLCs
- Cognex Vision Systems
- Sensors and Systech Serialization/Track & Trace systems
- Proven ability to troubleshoot, support, and validate automated control systems in a manufacturing environment.
- Experience with automation system lifecycle support, including system design, hardware/software installation, and validation documentation.
- Knowledge of process instrumentation, packaging machinery, and computer-integrated manufacturing systems.
- Familiarity with Design for Manufacturing (DFM) and custom mechanical assembly systems is a plus.
- Excellent written and verbal communication skills.
- Strong organizational, interpersonal, and leadership abilities, with the capability to work both independently and in team environments.
- This is a full-time, on-site position based in Columbus, OH USA
- Requires up to 25% travel, including domestic and international locations, depending on project needs.
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