This position reports to the Sr. Manager, QA Validation CMO, and is responsible for biological and/or small-molecule process validation activities in a cGMP environment. This position will coordinate and manage process validation projects related to the implementation of material packaging and shipping processes and changes to existing processes. In addition, the position will assist users with requirements development, process acceptance criteria, and regulatory agency assessments/reports. The position will also be a key contributor assisting with change control and regulatory responses in addition to the presentation of process validation activities during regulatory agency/partner audits and inspections.
The position organizes and performs validation activities with minimal supervision. Other responsibilities of this position include: protocol generation, project management, protocol execution, final summary report generation and other duties as assigned.
- Provide project management oversight for process validation activities related to BioMarin’s biologic/small-molecule material packaging and shipping operations.
- 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 approval 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 with oversight from manager.
- Coordinate 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
- Represent Validation in multi-departmental meetings & project teams owned by QAV Shipping Process.
- Identifies and implements improvements to the QA 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.
- Coordinate process validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others.
- 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 with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
- 5+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
- Training in project management is preferred.
- 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).
- 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.