PharmEng Technology
Job Details
Job Description
- Provide strategic leadership and guidance in compliance and operational improvement of equipment systems.
- Responsible for the development and maintenance of the utility master plan, drawings, flow diagrams and Standard Operational documents.
- Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
- Provide engineering support to address operational / compliance issues and to ensure equipment is maintained at a level required to provide high reliability maximizing useful life.
- Provide leadership and technical expertise for maintenance strategy for new and modified equipment and systems.
- Implement measures to improve equipment that support utility operations.
- Support commissioning and qualification activities. Ensure compliance with site and global indicators.
- Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements.
- Continuous Improvement of SOP’s, maintenance PM’s, BOM’s and Spare Parts
- Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure.
- Ensure 100% Utilities Equipment uptime providing technical support to utility operations and maintenance.
- Works on problems of complex scope where analysis of scenarios or data involves multiple competing factors.
- Utilize control systems to monitor, trend and verify equipment performance and downtime.
- Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production.
- Measure and ensure compliant performance in Safety, Quality and Reliability
- Demonstrate success of preventative maintenance improvements through performance reports, dashboards, and metrics
- Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
- Equipment is maintained at a level required to provide high reliability maximizing useful life.
- Oversee environmental monitoring and laboratory sample release test results.
- Peer review root cause analysis around equipment and operational events, support complex change controls, investigations.
- Lead complex investigations using Root Cause analysis capability.
- Responsible for Process Safety Management and Hazard Reviews (PSSR’s, PHA’s, etc.)
- Responsible for the development and maintenance of the utility master plan, drawings, flow diagrams and Standard Operational documents.
- Responsible for utility inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
Job Requirement
- 7+ years of experience in an engineering management role in support of a large industrial, pharmaceutical, biotechnology or FDA regulated facility
- Demonstrated knowledge of Reliability Engineering concepts such as TPM, RCM, RBI, FMEA and RCFA experience with process improvement principles such as Lean and/or Six Sigma
- Demonstrated experience in Vibration Analysis, Ultrasound Scanning, Infrared Scanning, Oil Analysis, Eddy Current, Liquid Penetrating testing, Dynamic/Static Motor Current testing, etc
- Proficiency in Power BI is a plus.
- Experience with Quality Management and Change Control Systems.
- Knowledge of computerized maintenance management systems (CMMS).
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Knowledge & experience in the operations and maintenance of utility systems
- Knowledge of manufacturing processes
- Strong Leadership skills
- Financial experience with high level budgetary responsibilities
- Computer skills: MS Office Suite, MS Project, and AutoCAD.
