Manufacturing Specialist

Overview

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join our new FDB facility in Thousand Oaks, CA and help manufacture the next cell therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

The Manufacturing Specialist works as part of the Manufacturing Services team delivering on team goals to generate high quality materials used both in the clinical settings as well as commercially.  The Specialist serves as the Manufacturing Owner of activities across manufacturing operations, including deviation record ownership, investigations, CAPAs, change control, risk management, and various manufacturing support functions.

External US

Reports to:  Director or Senior Manager

Work Location:  Thousand Oaks, CA 

Travel:  Travel required (Up to 10%)

Primary Responsibilities:

• Investigates deviation events that occur during the manufacture of products.
• Generates/authors investigation reports to address nonconforming events.
• Effective use of structured methodologies, including Causal Factor Analysis, DMAIC, Process Mapping, Kepner Tregoe, or similar problem-solving tools to gather and analyze data to identify severity, support conclusions and determine root causes of deviations.
• Collaborates with technical teams, as necessary, to perform impact assessments for deviations and change control records.
• Supports activities and documentation related to corrections, corrective actions, and preventive actions to mitigate impact and eliminate reoccurrence.
• Defining CAPA Effectiveness Checks and monitoring for performance.
• Serves as a change control owner.  Works with cross-functional teams and the Change Control Review Board to ensure change records are properly defined, assessed, planned, implemented, reported, and tracked.
• Drive work streams and associated Quality Management System records to implementation/closure to support on-time operational readiness and product availability.
• Supports manufacturing-related risk management activities and mitigation efforts to reduce potential 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.
• Leads planning, scheduling, executing, improvements, and reporting on manufacturing projects and support programs and processes.
• Defines and analyzes key performance metrics to drive continuous improvement across manufacturing operations.
• Support regulatory inspections/audits and serve as a subject matter expert on completed investigations, CAPAs, and change control records.

Qualifications:

• Bachelor of Science and 5 years’ experience.
• Excellent analytical, interpersonal, verbal, and technical writing skills.
• Proficient in using Microsoft applications (Word, Excel, PowerPoint, Project). 
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Self-motivated, flexible, and creative leader, able to prioritize, multi-task, and work in a fast-paced and demanding 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 organizational and project management skills.
• Motivates team members; fosters and nurtures teamwork.
• Proficient in problem solving tools, including DMAIC, Causal Factor Analysis, or Kepner Tregoe is preferred.
• Certified Six Sigma Green Belt, or greater, is preferred.
• Role model for company core values of trust, delighting our customers, Gemba, and Genki.

Join us!  FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential.  We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

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.