Manager Facilities Operations and Maintenance

United States of America, California, South San Francisco

de fr es ru tr it pt zh ja

The responsibilities for this position may include, but are not limited to:

  • This position is responsible for operational, technical and compliance leadership in the SSF Site Operations - Facilities Operations and Maintenance organization and will report to the South Campus Manager.
  • Specific management responsibilities will focus on overseeing maintenance and repair operations which support the SMPS IMP areas in B43 and B47.
  • Manage team of 3-5 mechanics and planner/gmp-controller by providing GMP/regulatory compliance, technical direction, leadership and development.
  • Direct and provide guidance on facility matters to ensure, utilities & equipment are safe, compliant, reliable and efficient and delivered according to customer expectations. 
  • Interact with key customers and stakeholders and keep them apprised of priorities, status, continuous improvement initiatives.
  • Partner with key customers and vendors to align on and implement service and efficiency improvements.
  • Drive quality and on time performance, ensure all aspects of day to day operations are reliable, efficient and meeting right to operate compliance
  • Oversee equipment / Utility SOP reviews and ensure that they are accurate, compliant, safe and updated. Review and keep current all relevant Standard Operating Procedures (SOPs) and operating parameters.
  • Oversee and coordinate routine and non-routine maintenance within the production schedule; work closely with area owners to obtain information needed to assess equipment problems.
  • Assist in the intradepartmental planning and development of preventive maintenance (PM) routines and associated schedules to ensure peak productivity and highest quality possible.
  • Ensure on time execution of work orders and establish and maintain monthly KPI tracking metrics.
  • Manage change controls and discrepancy events and ensure on-time closure. A critical part of the job will be to conduct investigations and recommend Corrective & Preventive Actions (CAPAs) for any utility or equipment discrepancy
  • Support: Roche internal and external audits and CAPA remediations.
  • Support: Construction, Commissioning and Qualification Activities.
  • Evaluate System Impact Assessments (SIAs) / Criticality Assessments (CAs) in partnership with QA for utilities.
  • Identify opportunities for continuous improvement and pursue changes and upgrades to processes and procedures as warranted, including optimizing the maintenance strategies.
  • Ensure all safety LOTO procedures are accurate and followed.
  • Create and maintain GMP training map to include skills matrix, document training plans, and OJT skills assessments. 
  • Develop training content for new equipment / Installations including troubleshooting guides
  • Support technicians in LOTO development, maintenance repair, fault diagnosis and troubleshooting of manufacturing process equipment when needed. Acts as LOTO database administrator and ensures proper equipment available for program compliance.
  • Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.
  • Provide technical training content needed for execution of maintenance.
  • Interact and communicate appropriately with SMPS Manufacturing, Quality, IFM and Site Operations teams (i.e. FSPE, FDT, LES) to ensure satisfactory performance of mechanical systems and utilities.
  • Maintain LOTO equipment area and Confined Space Entry/Elevated Work equipment in accordance with Site EHS requirements
  • Manage contractor training for vendors hosted by FOM.  This includes IFM vendor training for alarm response. 
  • Provide appropriate coaching and direction to ensure the ongoing development and high performance of each individual team member.
  • Develop a culture of engrained quality and Continuous Process Improvement.
  • Ensure the highest levels of quality exist in all services and materials provided to customer groups.
  • Ensure all operations, facilities, equipment, and business processes comply with appropriate GMPs, GLPs, and safety regulations and procedures.
  • Develop appropriate workflows, business processes and procedures where gaps in quality or compliance exist.
  • Build GMP expertise within the FOM maintenance team.
  • Explore innovative technologies for improving how work is performed (efficiency, quality, safety).
  • Support project GMP document review and sign off to include: User Requirement Briefs (URBs), design specifications, equipment Factory Acceptance Test (FAT) protocols, Site Acceptance Tests (SAT) protocols, and commissioning protocols.
  • Participate in cross functional teams that require identifying assignable root causes for any product or equipment related deviations or anomalies, and then establish and implement the necessary corrective and preventive actions needed to ensure the incident or anomaly is prevented in the future.
  • Continually seek opportunities to create value for our customers and ensure high customer satisfaction.
  • Identify key stakeholder groups and individuals and build strong communication and collaboration channels. Hold frequent discussions regarding quality of services as well as future needs.
  • Build effective business cases for adding new services.
  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire team to achieve goals in the immediate and longer term. 
  • Manage and administer people processes including selection, hiring, promotion, and compensation and provide training of personnel on company and department policies systems and processes.
  • Build a culture of continuous improvement and model lean leadership principles.
  • Ensuring ongoing career development of staff, providing regular context to staff on how the work they are doing enables the development and manufacture of life changing medicines to patients.
  • Ensure that all compliance requirements are met for training, positive safety audit results, the creation of new ways to ensure a safer work environment.

Requirements:

  • BS / BA required in an Engineering or a Facilities-related field or 10 years relative experience.
  • Expert knowledge of cGMP regulations. Emphasis in small molecule manufacturing  and potent compounds preferred.
  • Experience working as a Maintenance Mechanic/Technician in a GMP environment is preferred.
  • Working knowledge of Refrigeration systems is desired.
  • Demonstrated ability to facilitate and manage high performing teams.
  • Demonstrated ability to review project construction drawings and provide evolving design comments.
  • Experience with GMP maintenance operations, document control processing within repair and maintenance operations.
  • Excellent customer service and communication skills, excellent written, oral, and presentation skills.
  • Strong interpersonal, communication, and organizational skills.  
  • Proven abilities to work effectively and efficiently in cross-functional teams. 
  • Successful demonstration of leadership, teamwork, problem-solving, and technical skills.  
  • A fundamental working knowledge of safety, customer service, and quality assurance concepts is required, including the application of Good Manufacturing Practices (GMPs). 
  • Be technically competent and assist with problem solving.  
  • Strong analytical skills: demonstrated ability to lead teams through business-critical problem solving and change.
  • Capable of analyzing, synthesizing and summarizing financial and/or qualitative data and translating such into high-­‐impact learning and opportunities.
  • Strong interpersonal, communication, and organizational skills.
  • Proven abilities to work effectively and efficiently in cross-­‐functional teams.
  • Successful demonstration of collaboration and teamwork.
  • Demonstrated experience leading a performance based, customer focused operational organization using effective client relationship and collaboration skills to manage multiple business relationships.
  • Passion for continuous process improvement.
  • Experience applying LEAN or other Operational Excellence methodology