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Specialist, Facilities Compliance Novato United States,  

Biomarin (company)

Posted on : 24 June 2017

Project Description

  • Our company  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. 
  • Our company will continue to focus on advancing therapies that are the first or best of their kind.       
  • Our company 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 our company 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.       

  • Facilities Services provides GxP utilities and performs repairs and preventive maintenance on facility and manufacturing equipment at our company s site. 
  • The Facilities Compliance group supports Facilities Services and general facility operations at our company by managing the System and Area Release (SAR) process, deviation reports, change control, and training as well as providing overall GxP documentation and compliance guidance.       
  • The Facilities Compliance Specialist 1 or Specialist 2 will interact frequently with different cross functional groups such as Quality Assurance (QA), Quality Control (QC), Engineering, and Manufacturing. The Facilities Compliance Specialist 1 or Specialist 2 will report directly to the Facilities Compliance Supervisor. 
  • Upon completion of training, the Specialist 1 or Specialist 2 will be able to operate in the deviation and change control systems and also act as a back-up for other Facilities Compliance group responsibilities (listed below).       
  • The final position offered will be based on the experience level of the selected candidate.       

  • Acquire knowledge and expertise in technical aspects of Metrology, Preventative Maintenance, Utility equipment, and Facility operations in general.           
  • Lead Investigator and Writer of Facilities Services Deviation Reports           
    • Recognize potential deviations and escalate to Facilities Management and QA               
    •  Investigate deviations thoroughly and conduct root cause analysis               
    • Collaborate with QA, stakeholders, and Subject Matter Experts (SMEs) and facilitate discussions to determine appropriate corrective and preventive actions (CAPAs)               
    • Write clear, concise, and comprehensive deviation reports for SME review with minimal back and forth               
    • Close deviations on time in accordance with expected cycle times and QA goals               
    • Research equipment history and facility processes in order to complete child investigations from groups outside of Facilities Services.               
  • Corrective and Preventive Action (CAPA) Implementation           
    • Facilitate completion of CAPAs which constitute changes to documents, equipment or processes. These corrective actions may or may not require CRs.              
    •  Complete checks to demonstrate effectiveness of CAPAs.               
  • Manage Change Requests (CRs)           
    • Initiate, write, and complete CRs for changes to Facilities operations and equipment with minimal supervision               
    • Drive procedural improvements that will increase efficiency and consistency of Facilities processes               
    • Facilitate regular meetings and interactions with cross functional groups (e.g. QA, Plant Maintenance, Engineering) to coordinate and implement changes to processes and equipment.               
    • For key projects, independently develop and maintain project timelines. Close CRs in a timely manner.               
    •  Identify and facilitate improvements to the CR process with respect to Facilities perspective               
    • Operate in Functional-Like-For-Like (FLFL) parts program               
  •  Coordinate and Track Training           
    •  Oversee effective, efficient, and compliant execution of the GMP training system as a department training representative for Facilities               
    •  Become familiar with company s Learning Management System (LMS), Compliance Wire               
    • Consult Facilities training Standard Operating Procedure (SOP) and with Facilities management to assign training to Facilities staff               
    •  Review Facilities training curricula for relevance to Facilities staff job descriptions               
    • Work with Facilities management to ensure cGMP compliance with respect to training due dates               
    •  Make suggestions for improvement regarding training opportunities and effectiveness               
    • Provide a positive reinforcing, open learning atmosphere. Set a good example in observance of GxP               
  • System and Area Release (SAR) Process           
    • Have a working knowledge of the SAR process. The SAR process takes GxP systems temporarily out of service and brings them back into use in a controlled manner.               
    • Be able to operate as a back-up as needed when workload is high or when primary SAR administrator is unavailable               
  • Pest Control           
    • Have a working knowledge the GxP pest control program               
    • Be able to operate as a back-up pest control coordinator as needed               
      •  Arrange site visits                 
      • Check contractor training records                 
      • Review contractor paperwork                 
  • Cleanroom Gowning and Training           
    • Undergo gowning, personnel, and material flow training to receive access to cleanrooms and utility yard               
    • Act as a qualified clean room access trainer for Facilities new hires and contractors               
  • Compliance Mentoring           
    • Act as a competent and approachable resource for both Facilities Services and other staff in Technical Operations when guidance is needed in relation to Facilities Compliance related issues               
    • Provide help and lend expertise to other Facilities Compliance team members as needed               
    • Make suggestions for increasing quality and efficiency of the Facilities Compliance group               
    • Demonstrate leadership by example and participation.               
  • Compliance with safety guidelines           
    • Use safety eyewear and footwear while inside a Facilities area               
    • Know appropriate emergency response procedures and evacuation route/assembly area in case of fire or earthquake                
    • Know locations of first aid kits, safety showers, and spill kits               
    • Report near misses, good catches, and safety incidents appropriately               

Required Skills:
  • 4+ years  experience in a GMP regulated environment, with exhibited knowledge or proficiency at facilities operations, validation and/or change control (with BA or BS in biological science or engineering)           
  • 2+ years  experience in a GMP regulated environment, with exhibited knowledge or proficiency at facility operations, validation and/or change control (with MS in biological science or engineering)           
  • Organizational and management skills to coordinate multi-discipline projects           
  •  Ability to speak, present data, and defend approaches in front of audiences and inspectors.           
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.           
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.  Experience and proficiency with other applications (such as MS Access a plus).           
  • Understanding and familiarity with deviation investigations, change control and related FDA & European regulatory requirements, guidelines, and recommendations (understanding of regulatory guidelines for other countries a plus).           
  • Experience in report writing with proficient organizational, spelling, grammar, and typing skills           
  • Ability to quickly learn and master Equipment/Work Order management software and Quality management software used for management of Facilities business and Quality systems           

Desired Skills:
  • Familiarity with Equipment/Work Order management software (CMMS/EAM) and Quality management software (TrackWise)         

  • BA or BS in a technical discipline (physical, engineering or biological sciences preferred but not required) with 4+ years related to pharmaceutical Facilities or Manufacturing Operations           
  • MS in a technical discipline (physical, engineering or biological sciences preferred but not required) with 2+ years related to pharmaceutical Facilities or Manufacturing Operations            

  •  This position requires ability to utilize a computer to perform tasks, including report generation.       
  • This position requires the ability to use a smart phone, and will require some limited on call response after business hours.       
  • Ability to perform gown activities and enter the Facilities utility yards and manufacturing plants are required.       
  • Other projects may include working with utility systems, process tanks, autoclaves, glasswashers, bioreactor systems, chromatography columns and controlling skids       

This position will interact with a wide variety of personnel within Technical Operations at the Site, including Facilities & Engineering, Quality Assurance, Quality Control, Supply Chain and Manufacturing.        

 No personnel directly report to Facilities Compliance Specialist 1 or Specialist 2.  Position will indirectly oversee, mentor or coach other Facilities staff in regards to Compliance and Quality.        

Equal Opportunity:
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.


Novato California

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