Job Description

The Position Key Responsibilities

• Primarily responsible for the maintenance and administration of GMP automation systems for Roche Singapore Technical Operations. This includes DCS and vendor packaged PLCs.
• Maintenance and operation of GMP automated systems such as bioreactors, centrifuges, purification skids, and utilities.
• Be capable of troubleshooting issues related to equipment and automation systems independently.
• Supporting evaluation of process discrepancies, developing corrective actions, and implementing corrective actions.
• Perform commissioning and qualification activities for automation systems.
• Strong knowledge of Control Systems and Instrumentation and shall serve as a Subject Matter Expert for process Risk Assessments and Hazards Analyses.
• 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.
• Adhere to the requirements specified in Automation related Roche’s quality policies/quality standards or related SOP.

• Adopt Roche’s good engineering practice documents as guidance documents when performing the work function.

• Provide 24x7 support when needed.

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

• B.S or M.S. in Mechanical Engineering, Chemical Engineering, Electrical Engineering or equivalent degree and relevant work experience/training.
• Minimum 5 years of experience in supporting computer validation activities of automation control systems.
• The candidate must have working experience with supporting or implementing projects on Control systems. Emerson Delta-V DCS or Rockwell Building Automation System (BAS) experience is a plus.
• 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 at Roche.
• 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.

Who we are At Roche, more than 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.