Sr. Engineer, Global Process ValidationLocation Novato, California
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.
This position reports to the Associate Director, Global Process Validation and is responsible for biological, gene therapy, or small-molecule process validation activities in a cGMP environment which can include drug substance and drug product processes. This position will coordinate and manage process validation projects related to the implementation of new manufacturing processes and changes to existing processes according to the three phases of process validation. Risk-based process validation activities include drug substance manufacturing processes, drug product filling processes, process simulations (media fills), filtration, mixing, sterilization, lyophilization, vial & syringe filling, API chemical synthesis, blending, tableting, powder filling, and packaging, etc.
Experience with various stages of clinical and commercial manufacturing in a Quality and/or process sciences roll is preferred. Experience with defining process validation requirements, experiment/studies, and defining acceptance criteria is necessary. Understanding and experience with change control and Health Authority requirements are highly recommended. Health Authority inspection experience is a plus.
The Senior Engineer organizes and performs process validation activities with minimal supervision within a cross-functional environment. Other responsibilities of this position include: protocol generation, project management, protocol execution, final summary report generation, CTD module generation, and other duties as assigned.
- Perform process validation activities related to BioMarin’s biologic/gene-therapy/small-molecule Drug Substance and Drug Products, through defined clinical and commercial stages.
- Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising judgment within broadly defined procedures and practices to establish acceptance criteria, and identify and implement solutions to meet BioMarin and Agency requirements.
- Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
- Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
- Determine methods and procedures on new assignments independently and in accordance with developed practices and procedures.
- May oversee and manage the activities of sub-teams.
- Maintain current knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
- Lead and represent Global Process Validation in multi-departmental meetings & project teams.
- Identify and implement improvements to the Global Process Validation systems (department level impact).
- Generation of process validation master plans, core validation master plans and additional supporting documentation.
- Coordination of process validation activities performed at multiple locations including contract laboratories, contract manufacturing/testing facilities and internal BioMarin laboratories.
- Coordination of process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- Other duties as assigned
The candidate will have a significant role in the approval of documentation and release of manufacturing systems and processes for cGMP use. This position is required to successfully complete projects in a timely manner supporting company goals and objectives. Decisions made by this position can significantly affect project timelines and the ability to manufacture drug substance/drug product meeting BioMarin and Regulatory Agency requirements.
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Training in project management is preferred
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
2+ years experience in a position utilizing formal project management a plus.
Experience with several unit operations and systems 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/inspectorate.
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 involvement with FDA & European regulatory requirements and guidelines.
Proficiency with technical summary report generation required.
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).
WORK ENVIRONMENT / PHYSICAL DEMANDS
This function will perform majority of work in an office setting, reviewing documents, participating in meetings, authoring documents. This function may perform up to 60% of its functions at a computer terminal.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; high pressure and temperature utility systems, risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required.
This position requires ability to utilize a computer to perform tasks.
This position will require interaction with multiple levels (from technicians up through Senior Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.
Position has no direct reports at this time.
Demonstrated proficiency and experience in developing and maintaining validation department within cGMP expectations for the manufacture of drugs at BioMarin.
Demonstrated proficiency and experience in maintaining and defending validation systems satisfying regulatory inspection scrutiny.
Demonstrated proficiency and experience in managing projects requiring multi-departmental coordination.
Demonstrated experience and knowledge of multi-departmental functions and issues (understanding the organization).
Successfully achieving project goals and meeting company deadlines in timely and cost-effective manner.
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.