Automation Engineer

Role: Automation Engineer

Location: Hopewell, NJ (Onsite)

Duration: 6 months with potential for extension

Experience Required: 10 years

Job Description Summary

The Automation Engineering Systems Administrator is responsible for the administration of the Supervisory Control and Data Acquisition (SCADA) system, as well as managing automation systems on GMP manufacturing equipment and instruments. Responsibilities include initial installation, ongoing maintenance, periodic backups, change control, validation, and system retirement. The candidate will also support additional GxP systems, such as Building Automation Systems (BAS) and Maximo.

The incumbent collaborates cross-functionally with internal departments, including Biologics Manufacturing, Facilities & Engineering, and Quality Assurance, as well as external resources to maintain SCADA, BAS, Maximo, and other GMP manufacturing systems. This role ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).

Essential Functions

• Perform GMP/GLP activities.
• Administer SCADA, BAS, Maximo, and other automation engineering systems.
• Monitor system performance and operability.
• Develop Change Controls to enhance systems and operations.
• Execute system modifications as per Change Control.
• Create validation protocols, reports, and lifecycle documents.
• Execute validation protocols.
• Manage automation systems for bioprocess equipment, including single-use bioreactors, chromatography controllers, ultrafiltration skids, and benchtop instruments.
• Author Change Controls and test scripts; serve as the Subject Matter Expert for applicable changes.
• Recommend and integrate new bioprocess equipment and Process Analytical Technologies (PAT).
• Prioritize and manage multiple concurrent projects and daily requests.
  
  

Liaise with Business, Managed Services, and IT to coordinate IT Change Request processes.

Maintain an up-to-date knowledge base of solutions and work with Managed Services sustainment teams to facilitate technical troubleshooting and repairs.

Knowledge, Skills, And Abilities Required

• In-depth knowledge of domestic and international regulatory guidelines (FDA, ICH, USP, EMEA) for equipment and systems validation.
• Familiarity with cGMP/GLP requirements, procedures, methods, and protocols.
• Bachelor’s degree in Electrical Engineering, Computer Science, IT, Engineering, or a related field, with at least six years of relevant experience in system automation validation and biologics production equipment/systems.
• Direct knowledge of biologics process equipment, SCADA/control systems, and validation practices.
• Expertise in scientific/technical areas, including Equipment Qualification, Computer System Validation, Cleaning Validation, SCADA system architecture, and Biotech Process Equipment/Systems.
• Proficiency in Microsoft Office and specialized software, including Veeva Vault, SAP, and Maximo.
• Expertise in Rockwell Automation (Allen Bradley) programming software and Wonderware SCADA systems; familiarity with OSI Pi is a plus.
• Strong analytical thinking and problem-solving skills, with the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization, and time management skills, capable of supporting and prioritizing multiple projects.