Project Management, Continuous Improvement, and direct Operational Support of Process Utilities (USP water systems, autoclave systems, gas systems, and associated support systems). The purpose of this role is to actively support project management, continuous improvement, and production support of all manufacturing utilities equipment at the bioMerieux, Inc. Durham Manufacturing Facility to produce cost effective quality product which meets all applicable regulatory standards and the needs of customers worldwide.
- Manages Process Utility Systems Projects and Continuous Improvement activities in adherence to FDA Regulations, GMP, ISO, HSE (OSHA) and QMS Site Procedures.
- Provides technical support to daily operations to ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
- Engineering technical contact for the Suppliers / Vendors associated with the Process Utility Systems.
- Manages and supports Process Utility Systems compliance activities such as Calibration Exceptions Reports (CER), Autoclave Alarm Responses, and other deviation or qualification activities.
- Works with maintenance, facilities, and engineering to maintain Durham site production goals and ensure that the manufacturing equipment meets and exceeds the Operating Equipment Efficiency (OEE) goals determined by World Class Manufacturing standards to support business demands.
- Provides and supports technical development of Maintenance Process Utilities team.
- Acts as a technical support partner for corrective maintenance activities as necessary and in compliance with site documentation and change control requirements.
- Leads root cause analysis and continuous improvement to equipment/systems driving toward increasing reliability and minimizing the incidence of unplanned downtime to production support equipment to ensure manufacturing line is operating at optimum level for a GMP environment in a Safe mode while meeting production goals.
- Develops within the Engineering team with the objective of implementing best in industry practices and standards to create more efficient and effective calibration and utilities operations at the site.
- Collaborate with the new MFG line equipment suppliers to establish Preventive Maintenance Schedules, Calibration Schedules, and Critical Spare Parts lists.
- Review OEE results, analyze data, and implement improvements as required.
- Review in process scrap and act to improve as required.
- Manage new process utility systems from commissioning and qualification activities performance qualification.
- Review equipment related non-conformances and determine root cause and corrective actions in an effort to reduce repeat events to minimize scrap and rework.
Experience and Qualifications:
- High School Diploma/GED with a minimum 15 years of technical experience focused on support of process utilities with mechanical/production level equipment required.
- Bachelor’s degree with a minimum 7 years of technical experience focused on support of process utilities associated with mechanical/production level equipment preferred.
- Minimum 5 years of Project Management and Continuous Improvement experience required.
- Minimum 5 years of experience working in an ISO regulated environment preferred.
- Commissioning, Qualification, and Validation activities experience preferred.
Knowledge, Skills, and Abilities:
- Demonstrated ability to exercise project leadership, diplomacy, and problem solving skills when coordinating and working within all levels of the organization.
- Computer Skills required; must be experienced and proficient in the use of:
- Basic Microsoft Office tools (specifically Word & Excel).
- CMMS experience desired.
- Excellent documentation and communication skills (written & verbal) within the team and external to department.
- Position requires strong attention to detail and GMP experience (including direct responsibility for change control, SOP generation/revision, and support of validation and commissioning activities).
- Ability to work successfully autonomously on independent projects as well as an active contributor on a team/shift in parallel with shift supervision responsibilities.
- Demonstrated initiative for increasing equipment reliability through in root cause analysis and implementation of sustainable solutions.
- Experienced with equipment change management and standard operation procedures (generation/revision).
- Demonstrating the behaviors of being a self-starter who is organized, detailed, conscientious, and ambitious. Lead by example.
- Technical support of process utility equipment systems to support manufacturing operating 24/7.
- Process Utility Systems support multiple high throughput manufacturing lines.
- This position has frontline responsibility for process utility systems (autoclave, water systems, gas, and support systems) decisions directly impacting the site manufacturing activities and product quality.
- Large and small scale project management of the process utility systems to cost effectively produce a quality product which meets all regulatory and customer needs.
- Support production through organizational management and as a people leader by demonstrating leadership behaviors: a self-starter who is organized, detailed, conscientious, and ambitious.
- A team player with a positive attitude, approaching projects/tasks with a sense of ownership and a focus on root cause analysis/sustainable failure prevention.
- Models behaviors such as being a team player with a positive attitude, approaching projects/tasks with a sense of ownership, and developing and improving the skill level and behaviors of others.
- Performs documentation requirements in a cGMP compliant manner in accordance with Quality Policies.
- Lead troubleshooting efforts to solve and address complex problems. Drive efforts in root cause analysis and continuous equipment/system improvement as well as infrastructure improvement toward the implementation of sustainable reliability based maintenance program.
- Plans, initiates, and tracks progress of work assignments to meet manufacturing schedules and needs; effectively communicates status across shifts, throughout Production, and to site management.
- Provides training, mentoring, and drives professional development.
- Ability to work effectively as part of a team in addition to autonomously as required.
- Able to read/redline electrical schematics, P&IDs, and mechanical/assembly drawings.
- Responsible to follow all site Safety Policies/OSHA policies including requirements as related to personal protection equipment as needed to perform routine and non-routine duties.
- Effectively communicates within team and interfaces with other site departments, verbally and written.