Job Description

The Position Key Responsibilities

• Responsible for engineering maintenance optimization of manufacturing equipment/systems (including associated utilities) serving the entire manufacturing facility and the execution of all job orders.
• Troubleshoot and provide technical support to a team of maintenance (mechanical) and calibration specialists on shift to perform engineering maintenance and repair of facilities and manufacturing equipment in support of plant operations.
• Provide support to manufacturing, utility and engineering services during routine and shutdown maintenance work; and product change over in support of plant operations.
• Performs timely review and technical completion of work orders, initiate follow up work order and discrepancy as required.
• Provide technical expertise in Mechanical, Electrical and Instrumentation maintenance to Project Engineering Team and deliver project within stipulated timeline and budget.
• Partner with Quality and Discrepancy owner to ensure timely closure of discrepancy records and related follow up actions.
• Analyze/create preventive maintenance procedures and/or practices to comply with regulatory codes, specifications, standards and corporate guidelines for the safe, reliable and efficient operation of the plant to ensure validity, efficiency, maximum production equipment uptime.
• Work with Reliability team to establish predictive maintenance program for the facility such as Thermal Scanning (IR), Ultrasonic, Vibration Monitoring etc.
• Increase the mean time between failure (MTBF) of equipment by identifying and eliminating the causes for recurring issues and to implement robust solutions.
• Partner with the Maintenance and Calibration team to reduce mean time to repair (MTTR).
• Implementation of continuous improvement project (Kaizen) and initiate change request to optimize maintenance/calibration activities if required.
• Review engineering specifications and design modification proposals to improve reliability within cost and other performance requirements.
• Coordinate with MRO storeroom personnel to establish and maintain the proper stocking levels of parts and equipment required to provide maximum equipment uptime at the lowest possible costs.
• Act as Reviewer and Approver for Maintenance Master Data.
• Represent Maintenance and Calibration team as the subject matter expert (SME) during health authority inspections.
• Carries out any other work and task as directed by Supervisor.

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 (education/experience/knowledge/skills/competencies)

• Degree in Mechanical, Electrical/Instrumentation or Chemical Engineering with at least 4 years experience in pharmaceutical or chemical manufacturing. (position level will be dependent on the years of relevant experience).
• Candidates with at least 2 years hands-on instrumentation and electrical engineering working experience in Pharmaceutical or Chemical manufacturing and experience in project start-up will be considered.
• Candidates with strong E&I background in a GMP environment will be preferred.
• Must possess in-depth technical knowledge in the area of mechanical and calibration maintenance to resolve a broad range of complex problems
• Strong background in Operation and Maintenance of equipment and instruments in the production and utility area.
• Experience in setting up SAP Maintenance Program, spare parts store, project start-up environment and safety procedures/practices is an added advantage.
• Excellent computer skills including but not limited to CMMS software, spreadsheets and word processing software.
• Excellent analytical problem solving skills and persistence to resolve outstanding issues.
• Excellent inter-personal and communication skills, both written and verbal.
• Must possess the ability to work independently with limited direction, and deliver projects/tasks on time and within budget.
• Must be team oriented and be able to lead and train junior members of the team.
• Strong leadership and customer service skills, attention to details, accurate and thorough.
• Strong concept of cGMP in area of Maintenance and Calibration.
• Willing to be scheduled to occasionally work off shift hours in support of operations.

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.