Key Responsibilities:

• Support the implementation and validation of automation systems for a new isotope manufacturing facility.
• Configure, troubleshoot, and optimize PLC systems (Rockwell and Siemens).
• Execute Computer System Validation (CSV) activities ensuring compliance with industry standards and regulations.
• Collaborate with cross-functional teams including engineering, quality, and operations to deliver project milestones.
• Apply a deep understanding of GMP and FDA regulations, including 21 CFR Part 11, throughout all project phases.
• Provide automation support for sterile and GMP manufacturing environments, including aseptic fill/finish operations.
• Utilize ISA-88 and ISA-95 standards to guide batch process control and industrial automation strategy.
• Support and troubleshoot isolator and equipment integration in a highly regulated manufacturing environment.
• Work closely with stakeholders and project teams to ensure timely execution of project tasks and milestones.
• May support second shift operations during key validation periods.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Automation, or a related technical field.
• Minimum of 7 years of relevant experience in the pharmaceutical or chemical manufacturing industry.
• Strong expertise with Rockwell and Siemens PLC systems.
• Proven track record in Computer System Validation and experience qualifying automation systems in a GMP setting.
• Deep knowledge of FDA regulations and GMP manufacturing requirements.
• Experience with aseptic fill/finish processes and/or radiopharmaceutical environments is preferred.
• Strong communication and interpersonal skills to engage and influence stakeholders at all levels.
• Excellent project management and problem-solving capabilities.
• Ability to operate with a sense of urgency and deliver high-quality work in a fast-paced environment.