Utilities Manager
2 weeks ago
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.
At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals.
We are seeking an experienced Utilities Manager. Our ideal candidate is a versatile engineering professional, with superior skills and experience in the optimization of procedure improvement and a willingness to work in a dynamic, on-site pharmaceutical project environment.
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 Requirements:
- 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.
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