The Utilities Value Stream Lead is responsible for supporting utilities engineering, site manufacturing, site labs, site warehouse and administration departments in all matters related to the establishment and operation of the utilities systems.
The Value Stream Manager will have cross-functional knowledge and experience to support all Plant Utilities. Applying a solid understanding of theories/practices toward the effective operations and maintenance of the utility equipment. Participates in the plans and execution of important operational and maintenance assignments. Assures cGMPs, SOPs, Division Procedures, and Good Engineering Practices are appropriately followed in all activities. You will have the responsibility and accountability to keep the facility and equipment in the assigned area operating in an effective and compliant manner.
- Provide guidance on the activities of the client services (supervisors, operators, technicians) to assure safe, timely, efficient, and compliant operation, and maintenance of all systems
- Oversee and manage equipment failure investigations and quality deviations through the triage process to endure timely resolution of any issues thus assuring a continuous supply of utilities and state of compliance with all applicable standards, methods, procedures, licenses and regulations
- Responsible to support change control activities, the implementation of CAPA items, perform investigations and determine/implement long lasting corrective actions and preventative measures
- Provide assistance with projects that enhance reliability for all Utility Systems
- Lead and participate in weekly GEMBA walks throughout the site (manufacturing and utility work environments), reporting and submitting work orders as well as incident observations in Zapatic accordingly
- Responsible to support the Value Stream's and attend their daily Tier meetings addressing all utility related items in their area
- Coordinate, oversee and manage contractors as needed to meet the responsibilities of the department
- Maintain equipment in sound condition, report and record deficiencies with recommended corrective actions
- Responsible for ensuring logbooks are correct and updated, work orders are tracked to completion and all equipment work related activity is properly documented and closed
- Evaluate clients performance in the completion and execution of technician related work orders and task lists. Endure completion of these executions are done in a timely, efficient manner
- Periodically verify appropriate training for client service employees on the shift (including but not limited too cGMP's, job skills, safety, etc.)
- Assists the department in developing policies, programs, SOP's, and quality standards to meet current industry, corporate quality, and external regulatory requirements
- Assist the Manager in operational oversight and leadership whit interfacing with Manufacturing, Metrology, Maintenance, Validation, QA, QC, R&D, Regulatory and various outside contractors
- Track, monitor, assess, and report operation and performance data that gives insight and indication of the stability and robustness of equipment and systems on an ongoing and forward looking basis as well as establish metrics to track the execution of preventative maintenance orders vs. due dates
- Communicates effectively with the Manager on issues and needs of the department
- Experience working in a Union environment is preferred
- Extensive knowledge of utility systems (Clean and Plant Utility Systems), cGMP and FDA regulated industries
- Knowledge of and familiarity with other plant operations, such as Manufacturing, QC/QA, etc.
- Able to manage multiple priorities in a utility plant environment
- Proven ability working on cross-site project initiatives