The Sr Validation Specialist is responsible for leading all validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with computer system validation regulatory requirements (e.g. 21 CFR Part 11) is always established and maintained.
The Sr Validation specialist is also responsible for leading qualification activities for production and laboratory equipment (i.e. steam sterilizer, incubator), utilities, processes validation, and cleaning validation at Capcium.
This includes prioritizing, developing validation/qualification strategies, executing, maintaining and coordinating qualification/validation activities, and serving as the liaison between IT department, operational business units and external 3rd party (where applicable). He/she will also review and approve documents (protocols and reports). The mandate also includes validation change management.