Sr. Engineer, Device QualityLocation Novato, California Apply
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.
The QSAT Sr. Device Engineer’s primary function will be to support combination products (device) Pre-market activities that focus on product realization up through regulatory filings and design transfer to manufacturing for commercialization. Specifically in the areas of risk management, design controls, and human factors. This includes the review and release of associated documentation for design controls, risk management and human factors into our document control system. Product lifecycle management documentation implementation, revision, control and traceability are in scope.
This position requires a broad range of knowledge and experience with the design and development of combination products and the regulatory requirements governing human use and commercialization.
- Support the premarket activities in the design and development of combination products.
- Take ownership and assist the processing of document deliverables into and within our electronic document management system (EDMS).
- Perform the required pre-market risk management activity to maintain the risk profile and associated controls for all device products.
- Perform periodic assessment of regulatory requirements against marketed products and associated controlled documents.
- Facilitate revisions to SOPs as required to support the current state of business.
- Collaborate with Process Sciences, MSAT, Manufacturing, Quality, and Regulatory organizations to advance the design and deployment of devices and combination products.
- Develop and grow strong working knowledge of principles and theories of well-controlled and robust commercial combination product manufacturing processes.
- Pre-approve and post-approve design and risk management documentation that result in DHF.
- Review and/or approve technical documents related to health authority submissions, PPQ deliverables, technology transfer, device performance and complaint monitoring, annual product reviews.
- Represent Quality in Device Quality and technology transfer activities, as well as pre-approval inspections for commercial licensure and product launch.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Participate in development and approval of MSAT Device and Combination Product design SOPs/Guidance documents with systemic procedural improvements.
- Maintain current knowledge of industry standards and regulatory requirements for combination products developed and manufactured by BioMarin.
- Provide technical leadership to support clinical and commercial combination product production at BioMarin and partner locations.
- Other duties as assigned
- Experience working in Quality Management Systems, specifically CFR Title 21 Part 820 and ISO 13485.
- Proficient with GxP practices in the Pharma and Medical Device Industries.
- Experience in working with Electronic Change Control Systems (EDMS).
- Experience in technical writing with SOPs, Work Instructions, Technical Reports, FMEA’s.
- Experience with updating risk assessments based on product complaint data processing.
- Experience with equipment and systems used in the manufacture of combination products.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of variable tiered audiences, scientific disciplines and health authority reviewers/inspectorates
- Ability to comprehend scientific/technical information related to devices and regulatory expectations
- Experience with participation in presenting or defending departmental functions in audits or regulatory inspections
- Understanding and demonstrated utilization of FDA & European regulatory requirements and guidelines
- Proficiency with authoring technical reports and strategies.
- Proficient with computer systems using the following software: MS Word, MS Excel, MS Outlook, VISIO
- Effective communicator using verbal, written and graphical techniques
- Effective working in a cross functional group and taking notes in meetings
Min 7 year of experience working in Pharma or Medical Device industries in a quality department role.
BS in engineering or sciences, or equivalent combination of education and experience would be considered.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.