Facilities Compliance Specialist
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.
Facilities Services provides GxP utilities and performs repairs and preventive maintenance on facility and manufacturing equipment at BioMarin’s Novato site. The Facilities Compliance group supports Facilities Services and general facility operations at BioMarin Novato by managing deviation reports and change control, supporting the System and Area Release (SAR) process, administering training, and providing overall GxP documentation and compliance guidance.
The Facilities Compliance Specialist will interact frequently with different cross functional groups such as Quality Assurance (QA), Quality Control (QC), Engineering, and Manufacturing. The Facilities Compliance Specialist will report directly to the Facilities Compliance Supervisor/Manager.
- Acquire knowledge and expertise in technical aspects of Instrumentation, Preventive Maintenance, Utility equipment, and general GxP facility operations.
- Demonstrate competence in Deviation/CAPA or Change Control systems
- Investigate and Write Facilities Services Deviation Reports
- Recognize potential deviations and escalate to Facilities Management and QA
- Investigate complex deviations thoroughly and conduct root cause analysis with minimal supervision
- 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 deviations for SME review
- Close deviations on time in accordance with expected cycle times and group/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, or processes. These CAPAs may or may not require Change Requests (CRs)
- Complete checks to demonstrate effectiveness of CAPAs
- Change Control
- Initiate, write, and complete complex CRs for changes to Facilities operations and equipment with minimal supervision
- Initiate emergency and urgent CRs as necessary
- 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, Plant Engineering) to coordinate and implement changes to processes and equipment
- For key projects, develop and maintain project timelines. Close CRs in a timely manner.
- Identify and facilitate improvements to the CR process with respect Facilities’ perspective
- Operate in Functional-Like-for-Like (FLFL) parts program
- Other Facilities Compliance Responsibilities
- 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 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
- Alarm Response
- Become familiar with alarm response process and provide guidance to Utility Operations and Plant Maintenance as necessary
- Work Order Audits
- Perform monthly work order reviews as required per SOP
- Support Internal and External GxP audits
- Provide supporting documentation as requested, such as training records, work orders, and quality reports
- Represent Facilities Services during GxP inspections and speak to inspectors/auditors when required
- Power Outage Response
- Help with immediate response as needed (i.e. identify impacted utilities and areas and initiate SARs)
- Assist with communicating power outage details and impact to affected groups. Coordinate meetings and product impact assessments.
- Coach mechanics and operators on power outage documentation
- Compliance Mentoring
- Act as a competent and approachable resource for both Facilities Services and other Technical Operations staff
- Be available for limited on-call response after business hours as needed
- 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
- System and Area Release (SAR) Process
- Compliance with Safety Guidelines
- Use safety eyewear and footwear when 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
- 3+ years’ experience in a GxP regulated environment, with exhibited knowledge or proficiency in manufacturing, facility/engineering operations, and/or quality processes (with a BA or BS in a technical discipline)
- 2+ years’ experience in a GxP regulated environment, with exhibited knowledge or proficiency in manufacturing, facility/engineering operations, and/or quality processes (with a MS in a technical discipline)
- 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 Microsoft Word, Excel, and PowerPoint. Experience and proficiency with other applications (such as Access and Project a plus).
- Understanding and familiarity with deviation investigations, change control, and related FDA and 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
- Familiarity and experience with equipment/work order management software such as CMMS/EAM
- Familiarity and experience with quality management software such as TrackWise
- BA or BS in a technical discipline (preferably physical, engineering, or biological sciences) with 3+ years related GxP experience
- MS in a technical discipline (preferably physical, engineering, or biological sciences) with 2+ years related GxP experience
- This position requires the ability to utilize a computer to perform tasks
- This position requires the ability to use a smart phone
- This position requires the ability to perform clean room gowning and enter GxP clean rooms, labs, and utility yards
- Activities may include working with utility systems, process tanks, autoclaves, glassware washers, bioreactor systems, chromatography columns, and controlling skids
- This position will interact with a wide variety of personnel within Technical Operations and the Novato site, including Facilities and Engineering, Quality Assurance, Quality Control, Supply Chain, and Manufacturing
- No personnel directly report to the Facilities Compliance Specialist. This position will indirectly oversee, mentor, or coach other Facilities staff in regards to compliance and quality.
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.