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Metrology and Maintenance Manager
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Berkeley, CA Berkeley, California |
About this job
Division: Siemens Healthineers
Business Unit: Strategy & Innovation
Requisition Number: 221023
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
Division Description:
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world's largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers' needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Job Description:
Position Overview
The QualityMetrology/Preventative Maintenance Manager provides leadership and hands on technical support for medicaldevice equipment and associated instruments for our Molecular products located in Berkeley, CA The Manager willensure any modification, installation, preventative maintenance; calibration,operational support, repair, or troubleshooting activity is properly staffedand supported in compliance with engineering specifications, the Food and DrugAdministration (FDA), and Good Manufacturing Practices (GMP) guidelines. Theindividual will be the (SME) for all aspects of the Maintenance and Calibrationprograms. This position requires the ability to lead, direct, and grow amaintenance department, chair meetings, present topics to the leadership team,provide constant, thorough and professional communication throughout all levelsof the organization.
Role Responsibilities:
* Manage PreventativeMaintenance/Calibration/Repair Program
* Prepare, maintain,and follow procedures for the maintenance, calibration, and associatedprocesses to adhere to cGMP's, company, local and state requirements.
* Support efforts to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
* Coordinate shutdown activities and scheduling of calibration/PM/repair work.
* Develop, conduct and document test methods for instrument systems troubleshooting
* Review Calibration/Maintenance Paperwork and evaluate breakdown and calibration statistics and adjust plans to suit.
* Increase overall equipment availability through reduction of breakdowns.
* Monitor equipment operation and implement corrective actions for out of specification operation and alarms.
* Increase overall instrument performance through optimization of calibration activities.
* Monitor instrument calibration results and implement corrective actions for out of specification conditions.
* Support Quality Assurance investigations of breakdowns and calibration failures.
* Coordinate equipment and instrument breakdown repair activities and serve as customer point of contact.
* Facilitate completion of change control documentation.
* Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
* Serve as site owner and subject matter expert of maintenance and calibration systems
* Prepare and manage shutdown schedules.
* Develop and implement improvements through cross-functional interactions.
* Develop, review, revise, and maintain SOPs for all equipment, utilities and maintenance and calibration processes.
* Provide day to day supervision including oversight of work quality.
* Manage staffing levels to ensure coverage of manufacturing and lab operations.
* Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
* Remain current on industry and FDA engineering standards and trends.
Required Skills, Education andCompetencies:
* Bachelor's Degree in mechanical/electrical engineering
* Minimum 10 years of experience in medical device or pharmaceutical or similar regulated industry preferred.
* Minimum 5 years maintenance supervisory experience required.
* Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, Excel and SAP.
* Must be a creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills.
* Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write procedures that clearly define required tasks. Ability to proofread other's work for accuracy. Ability to generate presentations/reports to explain and/or analyze areas of responsibility.
* Effective oral and written communication skills, acute attention to detail, excellent time and project management skills, and the drive to complete projects thoroughly is required, as is the ability to handle multiple priorities in a fast-changing work environment.
* Comfortable establishing culture of performance. Able to effectively delegate while retaining oversight of important tasks.
* Hands-on ability to isolate problems and identify root cause of issues.
* Ability to acquire data, to organize, to analyze, and reach accurate conclusions.
* Working knowledge of statistical methods used to develop metrics.
* Ability to teach others how to analyze data to identify trends and establish corrective actions.
* Understanding of engineering principles as they apply to facility and production equipment.
* Understanding of maintenance and calibration strategies and techniques. Understanding of Continuous Improvement Principles.
* Understanding of engineering principles as they apply to scientific instruments.
* Experience with calibration systems and metrology concepts.
* Detailed knowledge of process control and instrumentation systems.
* Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing. Experience with regulatory interaction/auditing.
* Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's).
What can Siemens-Healthineersoffer you?
* Full health benefits including medical, dentaland vision available to you on day 1
* Matching 401k program
* 20 Days of PTO + 10 observed holidays
* Tuition Reimbursement
* Career Advancement
Please visit our career site at http://www.usa.siemens.com/healthineers/careers
Business Unit: Strategy & Innovation
Requisition Number: 221023
Primary Location: United States-California-Berkeley
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 15%
Division Description:
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world's largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers' needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Job Description:
Position Overview
The QualityMetrology/Preventative Maintenance Manager provides leadership and hands on technical support for medicaldevice equipment and associated instruments for our Molecular products located in Berkeley, CA The Manager willensure any modification, installation, preventative maintenance; calibration,operational support, repair, or troubleshooting activity is properly staffedand supported in compliance with engineering specifications, the Food and DrugAdministration (FDA), and Good Manufacturing Practices (GMP) guidelines. Theindividual will be the (SME) for all aspects of the Maintenance and Calibrationprograms. This position requires the ability to lead, direct, and grow amaintenance department, chair meetings, present topics to the leadership team,provide constant, thorough and professional communication throughout all levelsof the organization.
Role Responsibilities:
* Manage PreventativeMaintenance/Calibration/Repair Program
* Prepare, maintain,and follow procedures for the maintenance, calibration, and associatedprocesses to adhere to cGMP's, company, local and state requirements.
* Support efforts to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
* Coordinate shutdown activities and scheduling of calibration/PM/repair work.
* Develop, conduct and document test methods for instrument systems troubleshooting
* Review Calibration/Maintenance Paperwork and evaluate breakdown and calibration statistics and adjust plans to suit.
* Increase overall equipment availability through reduction of breakdowns.
* Monitor equipment operation and implement corrective actions for out of specification operation and alarms.
* Increase overall instrument performance through optimization of calibration activities.
* Monitor instrument calibration results and implement corrective actions for out of specification conditions.
* Support Quality Assurance investigations of breakdowns and calibration failures.
* Coordinate equipment and instrument breakdown repair activities and serve as customer point of contact.
* Facilitate completion of change control documentation.
* Provide technical troubleshooting support to mechanics/technicians responding to breakdowns.
* Serve as site owner and subject matter expert of maintenance and calibration systems
* Prepare and manage shutdown schedules.
* Develop and implement improvements through cross-functional interactions.
* Develop, review, revise, and maintain SOPs for all equipment, utilities and maintenance and calibration processes.
* Provide day to day supervision including oversight of work quality.
* Manage staffing levels to ensure coverage of manufacturing and lab operations.
* Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
* Remain current on industry and FDA engineering standards and trends.
Required Skills, Education andCompetencies:
* Bachelor's Degree in mechanical/electrical engineering
* Minimum 10 years of experience in medical device or pharmaceutical or similar regulated industry preferred.
* Minimum 5 years maintenance supervisory experience required.
* Must be proficient in the use of Microsoft Office Applications, including Microsoft Project, Word, Excel and SAP.
* Must be a creative thinker with good interpersonal relationship skills, strong project management and process improvement skills, as well as strong cross-functional teamwork skills.
* Ability to clearly and concisely express thoughts in written procedures, protocols, and reports. Ability to write procedures that clearly define required tasks. Ability to proofread other's work for accuracy. Ability to generate presentations/reports to explain and/or analyze areas of responsibility.
* Effective oral and written communication skills, acute attention to detail, excellent time and project management skills, and the drive to complete projects thoroughly is required, as is the ability to handle multiple priorities in a fast-changing work environment.
* Comfortable establishing culture of performance. Able to effectively delegate while retaining oversight of important tasks.
* Hands-on ability to isolate problems and identify root cause of issues.
* Ability to acquire data, to organize, to analyze, and reach accurate conclusions.
* Working knowledge of statistical methods used to develop metrics.
* Ability to teach others how to analyze data to identify trends and establish corrective actions.
* Understanding of engineering principles as they apply to facility and production equipment.
* Understanding of maintenance and calibration strategies and techniques. Understanding of Continuous Improvement Principles.
* Understanding of engineering principles as they apply to scientific instruments.
* Experience with calibration systems and metrology concepts.
* Detailed knowledge of process control and instrumentation systems.
* Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing. Experience with regulatory interaction/auditing.
* Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID's).
What can Siemens-Healthineersoffer you?
* Full health benefits including medical, dentaland vision available to you on day 1
* Matching 401k program
* 20 Days of PTO + 10 observed holidays
* Tuition Reimbursement
* Career Advancement
Please visit our career site at http://www.usa.siemens.com/healthineers/careers
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