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Senior Engineer 1 / 2, QA Process Validation

Location Novato, California
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. 

QA Process Validation provides scientific and technical support to BioMarin’s drug substance and drug product manufacturing operations, from cell culture through final formulation and drug product. PV works in collaboration with Manufacturing, Process Sciences, MSAT, Quality, Regulatory, and other technical and business functions in order to provide compliant Quality oversight and approval of manufacturing process validation.

This position reports into Novato Site QA-Validation and is responsible for the QA oversight of biological and gene therapy process validation, to include both steaming and cleaning validation. All validation activities are carried out in a cGMP environment which includes biologics/gene therapy drug substance and gene therapy drug product processes. Risk-based process validation activities include drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, vial filling, etc.

The candidate will have knowledge of the underlying scientific principles applied to the manufacture of biopharmaceuticals, and a keen interest in bioprocess operations. Experience applying quality assurance oversight to the different phases of clinical and commercial manufacturing is a must. Experience with defining process validation requirements, experiment/studies, and defining acceptance criteria is necessary. The candidate must have an understanding and experience with change control and health authority requirements and inspections. The role organizes and performs process validation QA reviews and approvals with minimal supervision within a cross-functional environment.

RESPONSIBILITIES

  • Collaborate with Process Sciences, MSAT, Manufacturing, Quality, and Regulatory organizations to establish a reliable state of manufacturing process control.
  • Develop and grow strong working knowledge of principles and theories of well-controlled and robust commercial manufacturing process to include cleaning, steaming and VHP processes.
  • Oversee and approve process validation as well as cleaning and steaming validation activities and deliverables related to BioMarin’s biologic/gene-therapy Drug Substance and Drug Products, through defined clinical and commercial phases.
  • Pre-approve and post-approve (protocols, validation execution raw data reports and final report packages) process validation as well as cleaning and steaming validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to verify acceptance criteria applicability.
  • Review and/or approve technical documents related to health authority submissions, PPQ deliverables, technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and validation discrepancy report to support process transfer and process validation.
  • Represent Quality in process validation 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 Process Validation SOPs/Guidance documents with systemic procedural improvements.
  • Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and cleaning/steaming/VHP systems utilized at BioMarin.
  • Review and approve process validation master plans, core validation master plans and additional supporting documentation.
  • Provide technical leadership to support clinical and commercial drug substance and gene therapy drug product production at BioMarin Novato, including specification of process requirements, monitoring, analysis, and maintenance of the validated state of the manufacturing process.
  • Provide a science-based approach for resolution of discrepancies, deviations, investigations, and process issues through analysis of historical data and scale-down studies.
  • Other duties as assigned

EDUCATION

Bachelor of Sciences (BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

EXPERIENCE

  • 6+ years of experience
  • Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
  • Experience with unit operations and systems used in the manufacture of drug substance and drug product.
  • Experience with cleaning, steaming and VHP process validation used in the manufacture of drug substance and drug product.
  • 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 equipment, processes, 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 technical summary report generation
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications (such as Trackwise, JMP, MS Access a plus)
  • Experience with facilities, utilities and equipment qualification a plus


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.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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