Maintenance Engineer- CCP for Biomedical Manufacturing Industry

Responsibilities

• Execute equipment maintenance activities for corrective maintenance and ensuring preventative maintenance is completed according to schedule requirements, and support equipment change control implementations.
• Provide technical expertise for all process equipment related activities in the manufacturing process and support Maintenance Technicians.
• Utilize technical skills to lead process equipment deviation/atypical investigations, safety incidents and ensure effective root cause analysis.
• Conduct RTPS (Real Time Problem Solving) and FMEA studies to recurring failures by performing RCA and identifying corrective action.
• Implement technical solutions to improve equipment uptime and asset utilization through using MPS Lean Six Sigma Continuous Improvement Mindset.
• Lead Equipment QN investigation and develop robust solutions to prevent recurrence.
• Corrective Maintenance
• Ensure resolution and timely follow-up of identified production equipment and facility related equipment issues, unplanned events, and new opportunities identified by Maintenance team.
• Provide technical expertise and support the Maintenance Technicians for equipment breakdown, troubleshooting and recovery to ensure the timely and effective resolution of issues.
• Ensure equipment breakdowns are resolved in a timely manner and update the Preventive Maintenance Plan.
• Apply effective root cause analysis and troubleshooting Techniques to support the resolution of equipment-related incident and deviation/atypical investigation.
• Preventive Maintenance
• Review and conduct Preventive Maintenance (PM) optimization.
• Ensure all planned internal and external Preventive Maintenance (PM) activities completed timely.
• Update equipment critical spare part list and set minimum re-order levels in MRO CMMS system in optimized level.
• Compliance - Safety
• Participate in and support the implementation of actions for Incident Investigations and Audits.
• Risk Assessment owner for area of equipment as SME.
• Ensure required risk assessments, including HAZOPS, are carried out in a timely manner, recommendations provided, and implemented as agreed.
• Ensure permit requirements met IPT maintenance activities.
• Proactively review and challenge current activities to reduce safety risk for employees and quality risks for company's products.
• Compliance - Quality & Change control
• Develop SOPs and Job Aids to ensure compliance with regulatory standards and ensure PM related documents are generated and maintained according to required standards and frequency.
• Ensure all QN deviations/atypical are fully investigated with any equipment related actions effectively implemented within the agreed time frame to continually improve processes, prevent waste, and eliminate rework.
• Ensure all out-of-tolerance equipment findings are appropriately documented and investigated in a timely manner.
• Support implementation of Equipment change by participating in impact assessments and executing field equipment modifications, including management of project schedules, resource plans, vendor coordination, and material purchases.
• Prepare and complete IQ, OQ documentation and ensure that documentation meets required quality standards
• Equipment Project Management and Reliability improvement
• Support in RFC for CAPEX project and RBAM to improve equipment reliability.
• Utilize Lean Six Sigma Tools, such as Six Sigma, Kaizen, SMED, and 5S, to support execution of continuous improvement and OE projects intended to increase agility, flow and throughput, and also to reduce cycle time and inventory.
• Support development of a continuous improvement framework within the maintenance group and works with the Maintenance Lead to identify opportunities.
• Lead plant improvement processes to enhance availability, reliability, cost-effectiveness and efficiency of the plant.
• Participate in equipment/system-based FMEA.
• Self
• Demonstrate leadership behaviors in alignment with our leadership standards such as a Focus on Customer & Patients, Make Rapid Disciplined Decisions, Act with Courage and Candor, Build Talent, Demonstrate Ethics & Integrity, Drive Result and Foster Collaboration.
• Ensure both Operational Knowledge and technical Skill to the level required to discharge job responsibilities to consistently high standard.
• Demonstrate the inclusion Behaviors in interactions with others.
• WHAT YOU MUST HAVE
• Qualifications & Experience
• Degree in Mechanical / Mechatronics / Process / Chemical/Electrical or Instrumentation & Control Engineering
• 1-3 years of maintenance work experience in Pharmaceutical (Preferred), Chemical, Semiconductor, aviation, oil & gas or Petrochemical industry.
• Knowledge and experience working within a Computerized Maintenance Management System (CMMS). Familiarity with SAP is a plus
• Knowledge of parts inventory management, mechanical and electrical equipment design reliability principles
• Project management skill, includi

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