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