Key Responsibilities:

• Design, configure, and troubleshoot PLC systems (Rockwell and Siemens) for pharmaceutical manufacturing equipment.
• Support system validation activities, ensuring compliance with FDA regulations, GMP standards, and 21 CFR Part 11.
• Work closely with cross-functional teams in Engineering, Quality, IT, and Operations to deliver robust automation solutions.
• Apply ISA-88 and ISA-95 standards to develop and implement batch process control strategies.
• Provide technical support during installation, commissioning, and qualification phases.
• Deliver second-shift support for validation activities as needed.
• Maintain strong documentation and change control processes in accordance with regulatory requirements.

Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Automation, or a related field.
• Minimum 7 years of experience in automation engineering within the pharmaceutical or chemical industries.
• Strong experience with Rockwell and Siemens PLC systems.
• Solid understanding of Computer System Validation (CSV) and GMP system requirements.
• Familiarity with aseptic manufacturing, fill/finish operations, or radiopharmaceutical production preferred.
• Expertise in regulatory standards including 21 CFR Part 11 and GAMP5.
• Excellent communication skills and ability to work across multidisciplinary teams.
• Proven track record of successful project execution and stakeholder collaboration.
• Willingness to support a second-shift schedule during key project phases.