Key Responsibilities

• Lead the configuration, troubleshooting, and optimization of Rockwell and Siemens PLC systems.
• Support the implementation and validation of automation systems within a sterile GMP manufacturing environment.
• Execute Computer System Validation (CSV) activities, ensuring alignment with FDA regulations and industry best practices.
• Collaborate cross-functionally with engineering, quality, and operations teams to achieve project goals and milestones.
• Apply a deep understanding of FDA regulations and GMP requirements, including 21 CFR Part 11, throughout all project phases.
• Provide technical automation support for aseptic fill/finish operations and other sterile manufacturing processes.
• Utilize ISA-88 and ISA-95 standards to design and guide batch process control and automation strategies.
• Troubleshoot and support integration of isolators and complex manufacturing equipment in a highly regulated environment.
• Engage with stakeholders to manage project timelines and deliverables effectively.
• Provide support for second shift operations during critical validation or commissioning periods as needed.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Automation, or a related technical discipline.
• Minimum of 7 years of relevant experience in pharmaceutical or chemical manufacturing, preferably in a GMP-regulated environment.
• Strong hands-on experience with Rockwell and Siemens PLC systems.
• Proven expertise in Computer System Validation and qualifying automation systems in compliance with GMP requirements.
• In-depth knowledge of FDA regulations and industry standards for pharmaceutical manufacturing.
• Experience in aseptic fill/finish processes or radiopharmaceutical production is strongly preferred.
• Excellent interpersonal and communication skills with the ability to engage stakeholders across all levels.
• Strong analytical, project management, and problem-solving abilities.
• High sense of urgency and capability to deliver quality results in a fast-paced, dynamic environment.