Ultimate Solutions USA is seeking a highly skilled and detail-oriented Automation Engineer to provide technical engineering support across all phases of system and equipment optimization, including upgrades, replacements, and modifications. The successful candidate will ensure all operations are performed in compliance with corporate quality policies, FDA regulations, and industry standards. This role is critical to supporting the automation systems used in pharmaceutical packaging and manufacturing environments.

Key Responsibilities

• 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.

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Required Qualifications

• 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.

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Work Environment & Additional Requirements

• 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.

Ultimate Solutions Corp is an equal opportunity employer.