Job Description
Job Description
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 Reliability Engineering 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.
Main Responsibilities and Accountabilities
- Provide strategic leadership and guidance in compliance and operational improvement of equipment systems based upon pharmaceutical industry trends and emerging technologies.
- Ensure the Reliability Program is developed and implemented :
- Maintenance strategy and plans for new and modified equipment.
- Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
- Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts for accuracy, efficiency and in support of compliance with applicable regulations.
- Works on problems of complex scope where analysis of scenarios or data involves multiple competing factors.
- Manage and monitor KPI’s :
- Ensure compliance with site and global indicators.
- Measure and report reliability performance
- Demonstrate success of preventative maintenance improvements through performance reports, dashboards and metrics
- Serve as functional lead for initiatives and strategy development related to Integrated Facilities Management (IFM) and Maintenance, Repair and Operations (MRO).
- Accountable for support all global level processes, policies, procedures, and execution related to Maintenance, Utilities, Facility and Engineering Reliability.
Provides global governance support for the Maintenance Excellence Program in pursuit of best-in-class Maintenance and Reliability Engineering practices.
Establishes analytical tools and reporting methods for network standardization.
- Conduct analysis of system maintenance process and perform reliability studies :
- Use of reliability tools and processes such as Failure Modes and Effects Analysis (FMEA), Root Cause Analysis (RCA)
- Uses data to recommend improvements based on CMMS, FMEA, RCA and systems reliability data.
- Analyze equipment trends ensuring the maintenance program is effective
- Provide technical expertise and support :
- Ensure that the Preventative / Predictive Programs and Maintenance Planning Processes are executed.
- Evaluate new technologies (predictive tools) to be used by technicians and engineers.
- Accountable to effectively apply PdM technologies and non-destructing testing to minimize unscheduled / scheduled maintenance downtime.
- Possess strong technical knowledge and application of concepts, practices, and procedures.
- 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.
- Recommend and implement measures through global initiatives to improve equipment that support manufacturing operations in a dynamic, fast-paced cGMP, biotechnology environment.
- Participate daily in leadership meetings providing technical support in all matters pertaining to operations and maintenance of equipment systems.
- Maintain clear communication with the Director of Utilities regarding goals, projects, planning, and overall performance of the Utilities.
- Responsible for development of the department, placing a high priority on developing others through coaching, feedback, and developmental goals where team members experience personal and professional growth.
- Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of non-value added activities.
- Technical Representative for Regulatory Agency audits.
- Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
- Completes any other duties / responsibilities assigned by senior management.
Education
- Bachelor’s degree in chemical, Mechanical, Electrical Engineering preferred or B.S. degree in an Engineering related field.
- Certified Maintenance & Reliability Professional, preferred.
- Certified Reliability Engineer, preferred.
Experience
- 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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