Assume responsibility for authoring, executing & review/approval of SOP's, commissioning documentation, documents required for validation/qualification such as but not limited to URS, protocols, reports & support records to ensure compliance; timely resolution of documentation, compliance, and quality system issues.
Identify, coordinate, execute and provide oversight of validation activities related to the start-up, commissioning, qualification, validation of a new Biotech GMP manufacturing facility (including manufacturing equipment, QC lab equipment, utilities).
Perform environmental mapping and other miscellaneous validation activities
Evaluate and analyze validation data for accuracy and adequacy
Support the development of validation execution strategy and timeline for sustained operation within validated GMP environment
Responsibility for Validation Lifecycle documents including Validation Plans, Impact Assessments, and Validation Reports
Review and support IT and Computer Systems Validation efforts for global systems.
Manage workload to ensure timely approval of validation testing and documentation.
Assist Quality Assurance, Production, Quality Control and other departments during inspections or audits.
Education and Experience:
BS/MS degree in Engineering or Science with 4-8 years in the pharmaceutical or Biopharmaceutical industry with at least 4 years validation experience.
Experience with method and process validation
Experience with Biosafety cabinet smoke studies
Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
Experience supporting FDA approved, commercial products.
Experience in cGMP environment (IQ, OQ, PQ) is essential
Familiar with current industry best practices, including ASTM e2500 to plan efficient/risk-based validation projects
Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator
Familiar with GAMP 5 applications and practices