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This position reports to the Process Validation Manager and is responsible for multi-modality process validation activities in a cGMP environment. 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. Process validation activities may include drug substance manufacturing processes, drug product filling processes and completion of validation risk/impact assessments and evaluations, etc.
Job Responsibility:
Perform process validation activities related to BioMarin’s 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
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 supervision and in accordance with developed practices and procedures
May participate on sub-teams
Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin
Participate in multi-departmental meetings & project teams
Identifies and assists with implementation of improvements to 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 , Technical Development, Quality Control, Quality Assurance, Regulatory Affairs, and others
Requirements:
Bachelor of Arts/Sciences (BA/BS) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required
8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control
Organizational and management skills to participate in multi-discipline project groups
Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate
Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations
Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations
Proficiency with technical writing expected
Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point
Nice to have:
Training in project management is preferred
Experience and proficiency with other applications is highly beneficial
The ability to perform gowning activities and enter the manufacturing plant is preferred, but not required