BioMarin Pharmaceutical

Description

Senior engineer, CSA and Process Automation QA Oversight

Role

This position is responsible for Quality Assurance Validation (QAV) oversight of Computer Systems and Analytical instruments Validation, and the associated systems lifecycle management activities.

This role offers a diverse breadth of accountability spanning validation of Computer Systems, GxP software applications, manufacturing, QC and Bio- Analytical instruments, and process automation systems. This individual will work closely with Information Management (IM), Engineering, Regulatory, Manufacturing, QC, site QA, guiding the plan and design phase of projects and continuous process improvements in the manufacturing plant and lab environments. Supporting partners in identifying and navigating risk-appropriate qualification strategies will be critical to success in this role. This position requires a broad range of knowledge and experience with biologic processes, quality engineering and validation, and understanding of the international regulatory landscape. Experience with applications – DeltaV, PI, SCADA, Versiondog preferred.

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 individuals 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.

Key Responsibilities

• Provide Quality Assurance expertise and oversight for implementation of Computer System Validation (CSV), manufacturing, QC and Bio- Analytical Instruments, to ensure quality and compliance requirements are met.
• Actively drive Computer Software Assurance (CSA) approach including risk assessments, gap analysis, and system lifecycle management, ensuring systems are in compliance and operating within defined parameters.
• Provide guidance and QA oversight for Software Development Life Cycle (SDLC) documents like User Requirements, Functional & Software Specifications and Validation/Qualification protocols and test scripts.
• Provide oversight and support of the Quality Change Management process and activities associated with the implementation of new GxP computer systems and/or changes to existing validated computer systems.
• Provide guidance and support investigation and root cause analysis on CSV discrepancies and quality records (deviation, CAPAs).
• Responsible for the authoring and development of Periodic Reviews Reports for computerized systems across BioMarin.
• Represent QAV in multi-departmental meetings & project teams. Assist with coordination of qualification and validation activities involving cross-functional, multidepartment teams including Manufacturing, Engineering, Quality Control, Quality Assurance, Regulatory Affairs, and others.
• Provide quality oversight to support and follow BioMarin’s Data Integrity Program.
• Proactively contribute to the CSV functional strategies and long-term roadmap.
• Maintain knowledge of industry standards; FDA Computer System Validation Guidelines, FDA Computer System Assurance, 21 CFR Parts 210, 211, 11, 820, EU Annex 11, ISPE GAMP5, as it relates to computer systems used at BioMarin.
• Participate in computerized system audits and provide assessments to ensure compliant vendor/supplier management program and services.
• Represent the BioMarin Quality Systems and associated validation program, procedures, and deliverables to internal and external auditors and health authorities. Assist with answering questions from regulatory agencies, and with presentation of materials in regulatory inspections.
• Lead internal and contract resources to manage CSV activities and ensure adequate support to meet business needs. This may include hiring, training and managing resources, generation of Scope of Work Contracts and Purchase Orders (POs), generate request for proposals, review and approval of contractor proposals as well as budget management.
• Develop and report metrics on the ongoing and pipeline projects
• EDUCATION / EXPERIENCE:
• BS in an IT/IM/Computer Science or Engineering field or equivalent experience
• 8 to 10 years’ experience in CSV in the Life-science/regulated industry
• 3 to 5 years’ experience in Analytical Instruments validation
• 3 to 5 years working in the Quality area in biotech or pharma
• Experience in Deviations, CAPAs and Change Control Management
• Strong background and implementation experience on industry regulations (e.g., FDA CSV, FDA CSA, 21CFR210, 211, 820, Part 11, Annex 11, ICH Q9, Q10) and guidance’s (e.g., ISPE GAMP, MHRA)
• Good knowledge and implementation experience on Data Integrity requirements (e.g., ALCOA & ALCOA+)
• Strong decision making with ability to utilize critical thinking
• Experience with Computer Systems Periodic Reviews
• Experience with Veeva QMS and Quality Docs
• Experience with Analytical instruments
• Experience with PI
• Experience with automation applications like SCADA, DeltaV desirable
• Experience with ALM desirable
• Other duties as assigned.

SHIFT DETAILS

Days, with the ability to support emergent work off-shift to enable manufacturing, periodically.

ONSITE, REMOTE, OR FLEXIBLE

This role supports a hybrid working model with a minimum of 2 days onsite in Novato each week, and flexibility for more frequent onsite presence depending on projects and business support needs.

TRAVEL REQUIRED

Regular travel is not a requirement of the role, though some travel for conferences and global alignment initiatives will present opportunities for travel.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.