Senior engineer, CSA and Process Automation QA Oversight 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 groupis 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.
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Provide Quality Assurance expertise and oversight
for implementation of
C
omputer
S
ystem
Validation
(CSV)
,
manufacturing,
QC and
Bio-
Analytical Instruments
,
to ensure quality and compliance requirements are met.
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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.
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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.
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Maintain k
nowledge 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.
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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.
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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.
*
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
- Other duties as assigned.
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. 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. The salary range for this position is: $105,600 to $158,400. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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BioMarin Pharmaceutical Inc.
life insurance, paid time off
Apr 11, 2025