Automation Engineer (Manufacturing)

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.

Required Qualifications

Hands-on experience with :

Work Environment & Additional Requirements

Ultimate Solutions Corp is an equal opportunity employer.