DeltaV Automation Engineer

Ilb Enterprises - Warren, NJ

Full-time

Warren, NJ

Religious, Grantmaking, Civic, Professional, and Similar Organizations

About the position

The Automation Engineer will oversee the commissioning and qualification efforts for a Cell Therapy Manufacturing Project, ensuring that automation systems comply with project and regulatory standards necessary for production readiness. This role involves managing documentation, vendor interactions, and various qualification protocols throughout the project lifecycle.

Responsibilities

• Manage the lifecycle of all project-related documents for automation and commissioning activities.
• Set up and maintain a structured storage system in the designated document repository.
• Upload, track, and revise documents in real-time to align with project progress.
• Route documents for review and approval to ensure compliance with established procedures.
• Ensure all documentation complies with Good Documentation Practices (GDP) and is finalized for audit readiness.
• Develop commissioning schedules that outline the order and timeline for activities, with clear milestones.
• Define and document system boundaries to clarify the scope of commissioning for each subsystem.
• Prepare and track documentation for vendor interactions, including startup protocols and equipment certifications.
• Complete and document all Factory Acceptance Testing (FAT) processes.
• Conduct inspections and verification checks upon receiving equipment to ensure it matches project specifications.
• Perform on-site tests to validate that the equipment operates correctly within the installed environment, producing a detailed SAT report.
• Document the installation process, verifying that all components are installed according to design specifications.
• Ensure equipment performs as expected in its operational environment by executing OQ protocols and documenting results.
• Validate that the system meets all performance criteria and supports manufacturing needs, with comprehensive PQ documentation.
• Track and manage any changes to the systems or processes during execution.
• Confirm that all equipment and processes align with project specifications and regulatory standards.
• Ensure all automation activities comply with site and regulatory safety requirements.
• Provide consistent updates on commissioning and execution progress, budget, and schedule adherence.
• Work with C&Q, quality, and engineering teams to coordinate all automation deliverables and activities.
• Liaise with vendors for equipment setup, testing, and troubleshooting.

Requirements

• Bachelor's degree in Electrical Engineering, Computer Science, or related field.
• Minimum of 5 years of experience in automation engineering, specifically with DeltaV systems, within a GMP-regulated environment.
• Proficiency in DeltaV systems and experience with electronic documentation systems.
• Strong communication, documentation, and problem-solving skills.
• Ability to work collaboratively in a dynamic, team-oriented environment.