Engineer 1, QA Validation
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.
This position is responsible for development and process validation aspects related to cleaning and steam sterilization activities for biological manufacturing processes in a cGMP environment. This position will participate in and execute cleaning and steam sterilization process validation projects related to the implementation of new manufacturing processes and changes to existing processes. The position will primarily focus on new process implementation, changes, and revalidation, and may also assist users with equipment design, requirements development, process acceptance criteria, and health authority assessments/reports. The position may assist with change control and regulatory assessments. The position organizes and performs validation activities with oversight of the supervisor/manager. Other responsibilities of this position include: project management/tracking, protocol generation, execution, final summary report generation and other duties as assigned.
- Key area of focus pertains to cleaning validation (CIP/COP) and steaming validation (steam sterilization/SIP/Autoclaves).
- Assist with project management of cleaning and steaming process validation activities related to BioMarin’s bulk biologic Drug Substance and Drug Products.
- Assist with generation of project validation master plans.
- 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 defined procedures and practices to establish approval criteria, and identify and implement solutions.
- Assist with the development and implementation of SOPs/Guideline documents with systemic procedural improvements related to cleaning and steaming validation activities.
- Assist with the generation of cleaning limits for biological processes and familiarity of instruction guidance such as PDA Technical Report 29 and Technical Report 49.
- Determine methods and procedures on new assignments with oversight from supervisor.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
- Represent QA Validation in multi-departmental meetings & project teams owned by QA Validation.
- Assist with 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
- 5+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- 1+ years experience in a position utilizing formal project management.
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience and participation in regulatory inspections presenting departmental functions in audits or regulatory inspections
- 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).
- Understanding and familiarity with global regulatory requirements, guidelines, and recommendations for cleaning and steaming process validation expectations.
- Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Knowledge of industry standards, guidance documents, global requirements related to cleaning validation and/or steam sterilization is required.
Training in project management is preferred.
This position requires ability to utilize a computer to perform tasks.
This position will require interaction with multiple levels (from technicians up through Sr. Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.
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.