Sr. Engineer Global Process Validation
Global Process Validation (GPV) provides scientific and technical support to BioMarin’s drug substance and drug product manufacturing operations, from cell culture through final formulation and drug product. GPV works in collaboration with Manufacturing, Process Sciences, MSAT, Quality, Regulatory, and other technical and business functions in order to ensure efficient validation of manufacturing processes. GPV is responsible for receiving new processes from Process Sciences / MSAT, process monitoring and analysis (CPV), process performance deviations investigations, as well as establishment and maintenance of the process validated state and ongoing process improvement.
This position reports to the Assoc. Director Global Process Validation and is responsible for any of 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.
The preferred candidate will have a general knowledge of the underlying scientific principles applied to the manufacture of biopharmaceuticals, and a keen interest in bioprocess operations. Experience with various stages of clinical and commercial manufacturing in Quality 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 and inspections is a plus.
The Engineer 2/Senior Engineer 1 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.
- 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.
- Perform process validation activities related to any BioMarin’s biologic/gene-therapy/small-molecule Drug Substance and Drug Products, through defined clinical and commercial stages.
- Execute (protocol generation and approval, execution, and final package preparation and approval) 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.
- Author and/or review technical documents related to health authority submissions, PPQ deliverables, technology transfer, process monitoring, at-scale or scale-down studies, annual product reviews, and non-conformance (deviations/investigations) to support process transfer and ongoing manufacturing.
- Lead or participate in process validation and technology transfer activities, as well as health authority prior approval inspection for commercial license 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.
- Development and implementation of GVP SOPs/Guideline 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 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.
- Provide technical leadership to support clinical and commercial drug substance production at BioMarin Novato, including specification of process requirements, monitoring, analysis, troubleshooting, and maintenance of the validated state of the manufacturing process.
- Provide a science-based approach for resolution of deviations, investigations, and process issues through analysis of historical data and scale-down studies.
- 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
6+ years of experience for Sr. Engineer 1
4+ years of experience for Engineer 2
Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
4+ years of 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.
The ability to support international meetings within the BioMarin network (early morning / late evening)
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. #LI-JG1