SeniorValidationEngineer(I,II,III)

## Responsibilities Generate and develop qualification and validation lifecycle documents , templates, protocols, reports including but not limited to the following: SOPs related to the commissioning , qualification and validation programs, Risk Assessments, System Impact Assessments, Validation Master Plans, URS, project plans, Validation Master Lists Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems Ensure maintenance of validated status via Periodic Review (PR) and requalification activities Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems Knowledge of Data Integrity and ALCOA+ principles and the applicability to process and analytical systems Knowledge of QC equipment validation as it relates to the interface of IOQ and method validation Support vendor qualification activities including risk assessments and participate in selection of vendors that support validation effort Support the change control program with respect to facility, equipment, and utility validation changes. Evaluate validation impact of equipment introduction/upgrades and software/hardware changes Follow written SOPs, and ensure SOP training remains current Oversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, and Equipment Provide guidance on topics to foster a quality culture and quality mindset Actively participate in continuous improvement activities with cross-functional teams Provide status updates to stakeholders and internal customers of validation activities in their respective areas Identify qualification/validation gaps, strategize on solutions, drive gap mitigation Mentoring and training junior level engineers Foster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sites Participate