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Process Automation group is responsible for the Process Controls Systems (PCS), Information Management System (IMS), Building Automation Systems (BAS), and a number of GMP and non-GMP Programmable Logic Controllers (PLC) based skids.

Key Responsibilities

• Support and troubleshoot systems /network related issues for control systems.
• Maintenance and administration of the Emerson DeltaV Distributed Control System (DCS) and Syncade Manufacturing Execution System (MES), Rockwell & Siemens PLC-based system, PI Historian.
• Maintain software application interfaces, configure PI Historian components, create automated reports and software tools to support automation uses
• Perform troubleshooting systems issues independently.
• Write discrepancies, participate in investigations and develop / implement corrective actions.
• Maintain and support site level 3 MES (Syncade) by developing and managing site MES master data, performing data analysis and providing business system support.  
• Perform commissioning and qualification activities for automation systems.
• Strong knowledge of Systems and shall serve as a Subject Matter Expert for Systems Risk Assessments.
• Collaborate with other functional teams such as Manufacturing, Quality, Engineering and other functions of MSAT on cross-functional projects and responsibility e.g. Capable of leading continuous improvement projects and initiatives with involvement of other functional teams; directing the activities of contract engineering personnel.

Safety, Health & Environment:

• Comply with all RSTO’s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Observe all RSTO’s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives.

Qualifications

• BS or higher degree in Mechanical Engineering, Chemical Engineering, Electrical Engineering, Computer Science or equivalent degree with at least 5 years relevant work experience in the pharmaceutical industry
• Familiar knowledge of relevant health authority requirements/guidance and industry standards ISA S88 and ISA S95 for batch control and enterprise-control system integration; ISPE GAMP, ISPE Baseline Guide: Commissioning and Qualification, and ASTM E2500
• Experience with the design, implementation, commissioning, qualification/validation and maintenance of Manufacturing Execution Systems (MES), and/or Process Automation Systems (PAS). Experience or familiarity with Emerson Syncade MES, SAP S4 HANA, Mulesoft and Emerson DeltaV PAS is a plus.
• Knowledgeable about Windows Server Administration, SQL Databases, OPC communication, crystal report, software development for web based interface, integration with enterprise business systems (Mulesoft, LIMS, SAP, etc), TCP/IP, Cyber Security and Data Integrity concepts.
• Practical experience with quality risk management and risk-based validation approaches
• Strong technical writing, verbal communication, interpersonal and problem-solving skills
• Ability to work independently, organize and manage individual as well as lead larger scale projects
• Strong analytical skills for effective troubleshooting and problem solving
• Candidate should have a good understanding of Good Manufacturing Practice (cGMP), particularly as they relate to the operation, validation and maintenance of computer-controlled systems.
• Related working experience in a biotech or pharmaceutical operating environment is preferred.

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