Senior Calibration Engineer

5 days ago

Singapore VIATRIS ASIA PACIFIC PTE. LTD. Full time
About the Role

We are seeking a highly skilled Senior Calibration Engineer to join our team at VIATRIS ASIA PACIFIC PTE. LTD. in Singapore.

As a Senior Calibration Engineer, you will play a critical role in ensuring the accuracy and reliability of our manufacturing processes. You will be responsible for managing and maintaining our EAMS maintenance management system, supervising a team of Calibration/E&I Technicians, and performing day-to-day planning and scheduling of instrument calibration and maintenance activities.

Key Responsibilities
  • Manage and maintain the validated status of the EAMS maintenance management system by working with Quality Assurance team, Automation Information team, E/I maintenance team, and vendor on database, software, and hardware validation.
  • Supervise a team of Calibration/E&I Technicians to perform instrument calibration and instrument maintenance activities (CAL, COR, and repairs) according to procedures, good engineering practices, and cGMP.
  • Perform day-to-day planning and scheduling of instrument calibration and instrument maintenance activities to ensure smooth production.
  • Develop an instrument calibration and maintenance program to maintain plant instrument assets. Review and modify the PM Calibration to improve instrumentation, control, and reliability.
  • Be the System Administrator/SuperUser on EAMS applications and conduct training to new users.
  • Manage and utilize the EAMS as an effective tool to support the calibration team in compliance with cGMP and good maintenance practices.
  • Maintain the quality and accuracy of data integrity of the EAMS system.
  • Support manager to achieve financial objectives by preparing and controlling against approved annual maintenance budget; scheduling expenditures; analyzing variances; initiating corrective actions for instrumentation, control, and repairs.
  • Lead/participate in continuous improvement initiatives and support IRS/QAR investigations.
  • Manage and maintain calibration Standard Operation Procedure (SOP) by generating procedures for operation, review procedures, optimize procedures, and training of procedures to the E/I calibration team.
  • Manage and execute any modification and control of the calibration system in compliance with cGMP and good maintenance practices.
  • Track instrument performance and conduct benchmarking by tracking instrument breakdown, re-occurrence failure, and instrument history report to enable Maintenance Team to focus on areas that require attention.
  • Provide relevant operation and performance reports by generating reports on instrument maintenance work/PM statistics.
  • Support maintenance operations and shutdown activities by working with Supervisor and Engineer on developing the annual PM plan, setting work priorities; scheduling PM activities, coordinating resources planning to meet the schedule in a cost-effective way.
  • Implement and maintain calibration record filing system by keeping all calibration documentation records and reports for fast retrieval, audit ready, and comply to cGMP requirement.
  • Work with E/I Supervisor and Maintenance Planner to enhance maintenance activities on Global Reliability Program (GRP)/Preventive Maintenance Optimization (PMO).
  • Coordinate between the E/I and Production team; Area owners and Maintenance Repair & Operation (MRO) store on shutdown activities and major maintenance jobs, plan and schedule calibration/PM work orders accordingly.
  • Work with E/I Supervisor and Maintenance Planner on updating the Key Performance Index (KPI) established.
  • Liaise with Production to support new product tech-transfer, project construction, and commissioning through active involvement in commissioning activities; discuss instruments hardware improvement and modifications.
  • Maintaining good working relations with team by working closely with E/I, Automation, Production, and vendor in consultation with the team to resolve any issues.
  • Support Project team on special/urgent assigned projects to meet the requirement, schedule, and budget target.
  • Maintain a safe and clean working environment on areas under one's responsibility.
  • Provide training (e.g., OJT) and coaching to colleagues to build-up their competencies.
  • Participate IMEx Process Centric Team Tier 1 meetings and address engineering issues based on priority.
  • Develop or support TPM-OPC checklists, train, and coach operation team in OPC tasks and knowledge.
  • Complete all assigned training on-time and also prior to work execution.
  • Contribute to team effort by accomplishing desired results/KPIs.
Requirements
  • Degree/Diploma in Engineering related qualifications. Minimum 10 years of relevant experiences in pharmaceutical, chemical, or petrochemical industries.
  • Good working knowledge of CMS application, CGMP, GMI strategies, and PMO concept.
  • Knowledge of Reliability Maintenance, Right First Time technique, and performance-based management.
  • Experience in a large, global, and complex organization would be an advantage.
  • Able to handle multiple projects concurrently and possess project management experience.
  • Able to influence stakeholders or Business Leaders and to build trust throughout the organization.
  • Demonstrated capability to thrive in a complex and matrix environment.
  • Able to work with ambiguity.
  • Demonstrated problem-solving and relationship management skills.
  • Demonstrated consultative skills.
  • Consistently demonstrates clear and concise written and verbal communication.
  • Knowledge of cGMP and regulatory requirement related to instrument validation.
  • Good interpersonal skills and meticulous in producing quality output.
  • Proven teamwork and problem-solving ability, customer focus, and commitment to continuous improvement.
  • Ability to work effectively across functional teams and at multiple levels within the organization.
Preferred Qualifications
  • Master's degree.
  • Understanding of programming, and proficiency in at least one language.
Tell employers what skills you have:

Maintenance Management
Preventive Maintenance
Relationship Management Skills
cGMP Manufacturing
Construction
cGMP
Quality Assurance
Manufacturing Processes
cGMP Practices
Reliability
Planner
PMO
Reliability Engineering
CMS
Instrumentation
Petrochemical
Scheduling
Commissioning
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