Facilities Specialist

4 weeks ago

Newbury Park, United States FUJIFILM Corporation Full time

Overview:

The Facilities Specialist works as part of the Facilities team delivering on team goals to generate high quality materials used both in the clinical settings as well as commercially. The Facilities Specialist serves as the Facilities Owner of activities across Technical Operations and within Fujifilm Diosynth Biotechnologies, California (FDBC) Facilities Organization and Quality Management System, including: deviations, investigations, CAPAs, change control, risk management and various Facilities support functions.

External US:

Facilities Specialist

The Facilities Specialist works as part of the Facilities team delivering on team goals to generate high quality materials used both in the clinical settings as well as commercially. The Facilities Specialist serves as the Facilities Owner of activities across Technical Operations and within Fujifilm Diosynth Biotechnologies, California (FDBC) Facilities Organization and Quality Management System, including: deviations, investigations, CAPAs, change control, risk management and various Facilities support functions.

Reports to: Manager, Facilities Operations

Location: Thousand Oaks (northwest Los Angeles), CA

Primary Responsibilities:
  • Manage department deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
  • Drive improvements to the investigation process
  • Present investigations to regulatory inspectors, internal auditors, and management
  • Clearly communicate investigation progress to impacted areas and leadership.
  • Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule.
  • Advanced knowledge on Technical Writing
  • Collaborates with cross-functional teams, as necessary, to perform impact assessments for deviations and change controls.
  • Supports activities and documentation related to corrections, corrective actions, and preventive actions to mitigate impact and eliminate reoccurrence.
  • Serves as a change control owner. Works with cross-functional teams and the Change Control Board to ensure change records are properly defined, assessed, planned, implemented, reported, and tracked.
  • Draft and revise department procedures.
  • Supports Facilities-related risk management activities and mitigation efforts to reduce risks.
  • Contributes to the effectiveness of the Quality Management System, including identification and implementation of improvement opportunities for processes, procedures, and training to support deviation, CAPA, change control and risk management processes.
  • Defines and analyzes key performance metrics to drive continuous improvement across Facilities operations.
  • Manage Facilities, Engineering, and EHS training curricula.
  • Support regulatory inspections/audits and serve as a subject matter expert on completed investigations.
  • Support capital projects as needed.

Travel: Travel may be required (up to 10%).

Position Requirements:
  • Bachelor of Science and 3+ years experience, or Associates Degree and 5+ years' experience, or High School Degree and 7+ years' experience
  • Knowledge and understanding of regulatory governing bodies, requirements, and guidance documents, and how to practically apply these in a cGMP biopharmaceutical environment.
  • An understanding of foundational Quality systems (e.g., audits/inspections, Change Control, Deviation/CAPA, SOPs, etc.) and how to implement them effectively in a cGMP environment.
  • Proficient in problem solving tools, including DMAIC, Causal Factor Analysis, or is preferred.
  • Independent and risk-based decision-making capability with clear understanding of decision-making impact in dynamic startup environment.
  • Able to take ownership of a given assignment, proactively consulting cross-functional team members and other department representatives for information or guidance, as necessary.
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
  • Ability to work effectively and efficiently in a collaborative manner across multiple functional areas.
  • Experience in cGMP cell and gene therapy manufacturing and/or testing facility.
  • Basic knowledge of equipment maintenance, calibration and engineering programs.
  • Basic knowledge supporting internal/external audits by completing responses and tracking commitments.
  • Working knowledge with maintaining department training program and metrics.
  • Working knowledge of computer applications (e.g. Excel, Word, Tableau)
  • Working knowledge creating department month-end report analysis.
  • Strong organizational and project management skills.
  • Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding environment.
  • Role model for FDBC values of patients first, teamwork, innovation, community, and mindset.

Salary and Benefits:

  • $90,000 to $110,000 per year, depending on experience
  • Medical, Dental and Vision
  • Life Insurance
  • 401k
  • Paid Time Off

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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