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Facilities Specialist, Instrumentation Planning & Scheduling

Expired Job

Biomarin Novato , CA 94998

Posted 2 months ago

Facilities Specialist, Instrumentation Planning & Scheduling Location Novato, California Apply

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives.

JD- Facilities Specialist - Planning/Scheduling Instrumentation

Summary:

The position is responsible for providing a wide range of critical support for Facilities Services in the Maintenance Business Office (MBO). The focus of the position will be coordination, planning, scheduling and communication of GxP work orders across multiple buildings. Failure to efficiently evaluate the scope of work required by this position would have serious negative impact on compliance, equipment reliability, and manufacturing uptime.

Responsibilities:

  • Issue and assign maintenance and calibration work orders generated on a monthly basis. Assign other work orders as needed to support proper work order flow including movement to and from parts, execution, and compliance staff.

  • Communicate PM and calibration monthly workload to all affected supervisors.

  • Assist with scheduling equipment time with MFG for all impacting utility or process PMs, calibrations and repairs (coordinating with Manufacturing Planners).

  • Monitor and manage scheduling and planning inboxes in CMMS.

  • Participation in daily manufacturing planning meeting to determine equipment availability for impacting and non-impacting work.

  • Issue new work orders to follow up on ongoing issues, PM follow-up, or at the direction of supervision/compliance.

  • Evaluate priorities, planning and scheduling of unplanned work orders/requests. Requires coordinating multiple disciplines and trades.

  • Assist with reviewing work order requests for appropriate details and scope as part of the pre-execution review process. Work with CMMS users , FAC compliance, and execution staff to clarify work order scope as needed

  • Develop and support methods to assess and document parts required for planned work; assuring the availability of needed parts prior to scheduling.

  • Communicate controlled environment impacting work with Facility Compliance as needed for PMS, calibrations, and repairs.

  • Review PM schedules to align work in plants to better balance workload and to maximize PM intervals.

  • Work to eliminate excessive downtime to MFG by combining work when possible.

  • Review shift pass downs, emergency work, and new work requests to update customer on any new issues in a daily basis. Monitor parts updates for work requiring parts on orders

  • Coordinate and oversee HEPA testing campaigns.

  • Assist supervision and compliance in scheduling or communicating urgent or emergency work as needed

  • Categorize and monitor shutdown related work orders during production periods.

  • Assist planner with scheduling changeover, shutdown, and other projects as needed

  • Assist shutdown related activities during shutdown periods

  • Generation of planned preventative maintenance work orders (routine) and repair work orders (non-routine)

  • Contact and collaborate with external vendors to schedule work onsite

Daily Decisions:

  • Impacting and non-Impacting work to schedule

  • Compliance related: SARs, Change Request evaluation, potential quality events

  • Technician availability

  • Review of PM schedules to align with shutdown events

  • Daily WO review/approval requiring exercise of judgement and critical thinking in regards to escalation of serious issues.

  • Tracking of daily work to advise on return to service with area and equipment owners

Education and Qualification:

  • Bachelors of Arts/Science degree and a minimum 2 years work experience in heavily regulated industry required (pharmaceutical preferred).

Experience:

  • Solid understanding of GMP utility systems and manufacturing process equipment.

  • Strong working knowledge of GMP compliance requirements related to maintenance operations.

  • The employee must have the ability to perform a high volume of complex tasks with attention to detail.

  • Position requires exceptional organizational, communication, and critical thinking skills.

  • Position will require working within BioMarin enterprise software systems including, CMMS, Trackwise, Oracle, Bio-G, JIRA and Compliance Wire. Experience with one or more of these systems is highly desirable.

  • Strong working knowledge of GMP compliance requirements related to maintenance operations.

  • Strong understanding of parts planning and inventory control practices highly desired.

  • Strong computer skills, including Microsoft Excel, Word, Project, PowerPoint

  • Ability to read and interpret P&ID and other technical drawings.

Contacts:

  • There will be extensive daily contact with staff within Facilities (FAC Management, FAC Compliance, MBO-Parts, and Maintenance staff) as well as Manufacturing (Planning, Supervisors/System Owners).

Managed Projects:

  • Collaboration with Shutdown Project Manager to ensure all appropriate work orders are included in future shutdown scope.

  • Management of monthly work order generation.

  • Management of backlogged work orders.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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VIEW JOBS 10/27/2018 12:00:00 AM 2019-01-25T00:00 Facilities Scheduling Coordinator (TEMPORARY) Location Novato, California Apply BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients' lives. Duties The position is responsible for providing a wide range of critical support for Facilities Services in the Maintenance Business Office (MBO). The focus of the position will be coordination, scheduling, and communication of non GxP and GxP work orders across multiple buildings and campuses. Failure to efficiently evaluate the scope of work required by this position would have serious negative impact on compliance, equipment reliability, and manufacturing uptime. Responsibilities: * Assign maintenance and calibration work orders generated on a monthly basis. Assign other work orders as needed to support proper work order flow including movement to and from parts, execution, and compliance staff. * Assist with scheduling equipment time with MFG for all impacting utility or process PMs, calibrations and repairs (coordinating with Manufacturing Planners). * Monitor and manage scheduling and planning inboxes in CMMS. * Participation in daily manufacturing planning meeting to determine equipment availability for impacting and non-impacting work. * Issue new work orders to follow up on ongoing issues, PM follow-up, or at the direction of supervision/compliance. * Assist with reviewing work order requests for appropriate details and scope as part of the pre-execution review process. Work with CMMS users , FAC compliance, and execution staff to clarify work order scope as needed * Communicate controlled environment impacting work with Facility Compliance as needed for PMS, calibrations, and repairs. * Work to eliminate excessive downtime to MFG by combining work when possible. * Review shift pass downs, emergency work, and new work requests to update customer on any new issues on a daily basis. Monitor parts updates for work requiring parts on orders * Assist supervision and compliance in scheduling or communicating urgent or emergency work as needed * Categorize and monitor shutdown related work orders during production periods. * Assist planner with scheduling changeover, shutdown, and other projects as needed * Assist/lead shutdown related activities during shutdown periods * Contact and collaborate with external vendors to schedule work onsite Daily Decisions: * Impacting and non-Impacting work to schedule * Compliance related: SARs, Change Request evaluation, potential quality events * Mechanic availability * Daily WO review/approval requiring exercise of judgment and critical thinking in regards to escalation of serious issues. * Tracking of daily work to advise on return to service with area and equipment owners Skills Experience: * Solid understanding of GMP utility systems and manufacturing process equipment. * Strong working knowledge of GMP compliance requirements related to maintenance operations. * The employee must have the ability to perform a high volume of complex tasks with attention to detail. * Position requires exceptional organizational, communication, and critical thinking skills. * Position will require working within BioMarin enterprise software systems including, CMMS, Trackwise, Oracle, Bio-G, Quickbase, and Compliance Wire. Experience with one or more of these systems is highly desirable. * Strong working knowledge of GMP compliance requirements related to maintenance operations. * Strong understanding of parts planning and inventory control practices highly desired. * Strong computer skills, including Microsoft Excel, Word, Project, PowerPoint * Ability to read and interpret P&ID and other technical drawings. Education * Bachelors of Arts/Science degree is highly preferred * A minimum of 2 years work experience in heavily regulated industry required (pharmaceutical preferred). Skills and Experience The Skills and Experience match parameters for the candidate are parsed from the Duties, Skills, and Education. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. Biomarin Novato CA

Facilities Specialist, Instrumentation Planning & Scheduling

Expired Job

Biomarin