The purpose of this position is to establish and oversee procedures to ensure equipment involved in the collection of plasma is validated to critical validation standards as outlined by industry regulations and company policies. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
1. Develops and maintains equipment validation master plans (VMP), risk assessments, traceability matrices, test case protocols, test cases, validation reports and summary reports for plasma center operating equipment including plasmapheresis and plasma storage equipment, refrigerators and freezers.2. Coordinates supplier performed equipment validation to ensure compliance with regulations, policies, and procedures. Ensures supplier provided documentation meets requirements.3. Serves as consultant for test protocol execution and resolves issues.4. Reviews completed validation documentation to ensure actual results meet expected results.5. Reviews temperature excursions and equipment incident reports for appropriate and timely resolution.6. Ensures that all validation deviations are resolved, documented and reviewed for regression testing.7. Oversees the review and approval of operating equipment changes including impact assessment and presents to the Change Control Board.8. Defines and develops validation schedules to ensure that all plasma center equipment is periodically reviewed and assessed for revalidation.9. Develops reviews and revises standard operating procedures (SOPs) consistent with FDA and European Union (EU) regulations and customer requirements.10. Develops processes to maintain validated equipment status per the approved VMP.11. Tracks and trends equipment failures to support process improvement initiatives.12. Prepares monthly equipment validation metrics and reports metrics to the Sr. Director, Corporate Quality and Director, Field Quality. 13. Provides guidance to donor center personnel regarding validation policies andprocedures.14. Provides validation training materials as required and assists with training asassigned.15. Provides technical support during internal/external audits and regulatoryinspections.16. Audits current and/or prospective vendors.17. Submits performance objectives’ progress reports to Sr. Director, CorporateQuality.18. Manages departmental employees including training, performance evaluation,career development, compensation administration and progressive disciplineas needed according to company policies and procedures.19. Other job-related responsibilities as required.
1. Bachelor’s degree in life science or related field.2. Five years’ experience in biologics, biotechnology or pharmaceutical industrywith increasing validation responsibilities; or equivalent combination ofeducation and experience.3. Extensive knowledge of quality system regulations.4. Strong written and verbal communication skills.5. Plasma industry experience preferred.6. Advanced quality certification preferred.
1. Occasionally required to travel overnight.2. Frequently performs work while sitting.3. Required to communicate and interact with employees and vendors.