Senior Automation Engineer

Role Overview

• Support and oversee management of all on-site industrial controls systems BMS, PMS, EMS and PCS infrastructure and RLAN IT/OT architecture
• Lead and maintain Automation master plan for the entire site
• Manage life cycle and change control process for all automation control systems
• Provide support to maintenance teams for troubleshooting instruments and control systems
• Develop training programs for instrumentation and control systems to enhance team skills
• Manage vendors and consultants, ensuring contracts contain technical specifications
• Stay updated on developments in instrumentation and control technology
• Interface with users, peers, and management for appropriate input and integration of standards
• Provide technical expertise during regulatory audits
• Author, review, revise, or approve Standard Operating Procedures (SOPs)
• Oversee implementation of essential automation infrastructure from conception to completion
• Lead/Coordinate Factory Acceptance Test and Site Acceptance Test for all automation

Requirements

• Bachelor’s degree in electrical engineering, chemical engineering, automation engineering, or a related field is required
• 10 years managing automation systems experience in automation engineering, particularly in the pharmaceutical or biotechnology sectors is required
• Demonstrated experience in the design, implementation, and maintenance of automation systems within a GMP (Good Manufacturing Practice) environment
• Proficiency in PLC (Programmable Logic Controller) programming, SCADA (Supervisory Control and Data Acquisition) systems, DCS (Distributed Control System), and other automation technologies
• Knowledge of industry standards such as ISA-88, ISA-95, and GAMP (Good Automated Manufacturing Practice)
• Familiarity with regulatory requirements, including FDA regulations, cGMP (current Good Manufacturing Practice), and other relevant guidelines governing the pharmaceutical industry
• Technical Experience leading and managing automation projects from concept through commissioning, ensuring adherence to project timelines and budgets
• Understanding of equipment and system validation processes, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
• Ability to troubleshoot complex automation issues, identify root causes, and implement effective solutions
• Basic understanding of IT/OT (Information Technology/Operational Technology) digital concepts, with the ability to integrate automation systems EMS, DCS, PCS and BMS into broader digital frameworks
• Efficient Project Management skills
• Excellent written and oral communication skills for concise and practical presentations
• Proficiency in English, both written and oral.
• Computer proficiency with email; internet/online training; working knowledge of Microsoft Office, including Word and Excel; familiarity with manufacturing software programs

Benefits

• Competitive healthcare and retirement savings benefits
• An array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources