Senior Automation Engineer

Role: OPS ITOT SR Automation Engineer

Location: Milburn, NJ

Duration: 6 months

Job Purpose

The Senior Automation Engineer is responsible for the integration of new process equipment in addition to maintaining, troubleshooting, and modifying existing GMP and non-GMP control systems in Millburn, NJ. This includes plant wide SCADA, 3rd party skids, stand-alone control systems, Control Temperature Units (CTUs), air handlers, and Building Management Systems.

• Major Activities
• Provide technical expertise for the design, configuration, installation, and maintenance of automation software and associated hardware, including collaborating with other teams, as necessary.
• Oversee development of automation aspects of future projects including integration of 3rd party equipment to the plant DCS and Client systems, data concentration, batch reporting, and data retention.
• Support 24x7 site-based operations after startup.
• Prepare scopes of work and lead automation contractors as required to complete required work within project timelines.
• Develop project objectives working with user requirements and business plans.
• Determine equipment or system specifications and implement the most cost-effective technology to address those specifications.
• Participate in discussions with internal business partners on priorities and timelines, consistently supporting the transparent sharing of information.
• Develop equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS/HDS/SDS).
• Contribute to operational excellence and continuous improvement efforts.
• Problem solve technical issues impacting production.
• Create and update procedures to drive operational efficiency and compliance.
• Implement and revise SOPs to conform with standards and policies.
• Other related job duties as assigned.

• Key Performance Indicators
• Safety (Serious Injuries, Exposures)
• Quality (Batches Done Right First Time)
• Supply/Delivery: Service to patients (On Time in Full)
• Compliance (Audit and Inspection Results)
• Financial (budgeting and cost control)
• Ensures projects are executed on-time and within-budget
• Cultural surveys (Agreed Improvement Plans)

Requirements

• Bachelor's degree in Engineering or a related technical field.
• Proven experience with automation engineering in GMP-regulated pharmaceutical or biotech environments.
• Strong expertise in SCADA, DCS, and PLC systems programming, troubleshooting, and integration.
• Experience integrating 3rd party equipment and Building Management Systems (Client).
• Solid knowledge of GAMP 5, 21 CFR Part 11, and ISA-88/95 automation standards.
• Proven ability to manage projects and automation contractors, delivering solutions on time and within budget.