Offers “Roche”

26 days agoRoche

Senior Automation Engineer (SysMES)

  • Singapore (Central)
  • Teaching

Job description

·  Job facts

Purpose

·  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.
·  This role is part of a team of Automation Engineers handling all systems related aspects of the PCS, IMS and BAS, which includes but not limited to all servers and network related hardware, systems security and user management, database management, Data Integrity and Computer System Validation (CSV) deliverables.

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.

· 
Coordinate troubleshooting activities with technical SMEs and vendor teams to resolve system related issues.

· 
Adhere to the requirements specified in Automation related Roche's quality policies/quality standards or related SOP.

· 
Provide 24x7 support when needed to ensure production.

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 3 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 must be able to work well with others as a team member in an informal results- oriented work environment.

· 
Self-driven, Must have good communication skills (both verbal and written), and be able to work collaboratively with other groups.

· 
Experience in support of applications within FDA-regulated (GxP) environments.

· 
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.

· 
Knowledge of biological pharmaceutical production is desirable

Appointment to this position will be on the local Singapore salary and benefits package.

·  Who we are

At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.

Make every future a success.
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