Development of process validation protocols and other documentation for cell banking, cell culture and purification processes.
Write, execute, analyz490###.####45e results and summariz490###.####45e process validation activities related to tech transfer (new product introduction), change management, and continuous lifecycle management.
Develop and assess the following Quality System elements for Process Validation: Quality Risk Management program, CAPAs, Change Controls, Deviations, and GMP Investigations.
Participate and contribute in design, development, validation strategy, and routine GMP activities.
Provide technical input to strategy/philosophy for validation activities.
Represent process validation during tech transfer activities as required.
Represent process validation during site GMP activities and participate on cross-functional teams.
Own process validation Quality Systems, as required, and manage project through to closure per timelines.
Execution of process validation studies, as well as data analysis and compilation of data and results into summary and final reports.
Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
Own process validation related quality systems (CAPA, Change Control) and use project management skills to coordinate those project teams and drive results.
Qualifications & Experience:
Bachelor s Degree in Science or related technical field. Master s Degree is also preferred.
Minimum of 4+ years of experience in the biotechnology or pharmaceutical industries.
Must have demonstrated understanding of cGMP.
Strong experience with capital projects is necessary.
Proven ability to manage projects while meeting all deliverables and timelines.