Computerized Systems Validation Manager
Current• Ensure compliance and validated state of all GXP computerized systems in a 21 CFR Part 210 & 211 Good Manufacturing Practices (GMP) FDA-regulated environment.• Lead a team of validation engineers and external validation service contractors supporting computerized system validation (CSV) projects and initiatives.• Coordinate planning and scheduling of validation activities and deliverables.• Partner with Manufacturing, Automation Engineering, Technical and Quality functions to determine appropriate validation requirements and strategies for change control qualifications and ensure efficient execution test strategies.• Provide CSV assessments for change controls.• Review and pre-approve/post-approve Installation Qualification (IQ) and Operational Qualification (OQ) Process Control System (PCS), Manufacturing Execution System (MES) and Building Automation System (BAS) qualification protocols for completion, accuracy and Good Documentation Practices (GDP) compliance.• Interface with internal customers on OPEX and CAPEX technical issues, project timelines and validation support.• Support and participate in risk assessments and gap assessment activities.• Investigate and support the resolution and closure of deviations and associated Corrective Actions / Preventative Actions (CAPAs).• Review and approve validation plans, traceability matrices and risk assessments.• Perform CSV document periodic reviews.• Identify areas to optimize/streamline the validation process while maintaining compliance and good data integrity practices.• Provide validation systems training for new resources.