Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
Working with Pfizer’s dynamic engineering team, you will play a critical role in the management of manufacturing information systems to improve manufacturing success rates and ensuring zero down time.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- 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 the data base, software and hardware validation.
- Manage and 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 instrument calibration and instrument maintenance activities to ensure smooth production.
- Develop instrument calibration and instrument 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 user(s).
- 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 the 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 bench marking by tracking instrument breakdown, re-occurrence failure and instrument history report to enable Maintenance Team to focus on areas that required 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 and resources planning to meet the schedule in 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.
Qualifications
Must-Have
- Degree / Diploma in Engineering related qualifications. Minimum 10 years of relevant experiences in pharmaceutical, chemical, or petrochemical industries.Other Job Related Requirements:
- Good working knowledge of CMS application, CGMP, GMI strategies and PMO concept.
- Knowledge of Reliability Maintenance, Right First Time technique and performance base 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.
Nice-to-Have
- Master's degree
- Understanding of programming, and proficiency in at least one language
