Senior Automation Engineer

We are seeking a highly experienced Automation Engineer to support the design, implementation, and maintenance of automation systems for our New Jersey facility. The successful candidate will be responsible for ensuring that automation systems are operating efficiently, compliantly, and reliably to support manufacturing processes.

Key Responsibilities:

• Design, develop, and implement control systems to automate processes using PLC, HMI, and SCADA systems.
• Develop and modify automation software to enhance system performance and support production needs.
• Troubleshoot, diagnose, and resolve issues related to automation systems, ensuring minimal downtime.
• Work closely with cross-functional teams to integrate automation systems with existing manufacturing processes.
• Maintain compliance with GMP, GAMP, FDA, and other regulatory requirements.
• Create and update system documentation, including user requirements, functional specifications, and validation protocols.
• Participate in the execution of FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and commissioning activities.
• Provide support during audits and inspections to demonstrate automation compliance.
• Develop and deliver training to staff on automated systems and procedures.
• Collaborate with external vendors and contractors on system upgrades and new implementations.

Qualifications:

• Bachelor's degree in Engineering, Automation, or a related field.
• 10+ years of experience in automation engineering within the pharmaceutical or biotech industry.
• Proficiency with PLC programming (e.g., Allen Bradley, Siemens) and HMI/SCADA systems.
• Strong understanding of GMP regulations and automation standards.
• Experience with data historians, MES systems, and other manufacturing IT systems is preferred.
• Excellent troubleshooting and problem-solving skills.
• Ability to work independently and manage multiple projects simultaneously.

Preferred Qualifications:

• Proficiency in computer system validation and control system validation.
• Knowledge of batch processing and continuous manufacturing operations