Senior Technology Professional with expertise in pharmaceutical processes, equipment/computer systems specifications, operations, troubleshooting, qualification and validation, instrumentation, process control, Process Analytical Technology (PAT), software programming/configuration and related technical support. Will coordinate and conduct Computer System Validation and qualification to required systems and equipment. Develops and maintains administration and support model for process controls systems following applicable procedures. Provides and coordinates technical support for manufacturing, bulk packaging and lab equipment/systems. Assures that all assigned projects are conducted in compliance and following procedures and guidelines. Provides leadership and advance professional technical guidance in field of expertise to the organization. Support includes but is not limited to the following activities: Defines and manages validation strategy for Computer Systems/Equipment, considering operational and regulatory requirements. Writes Computer System Validation and equipment qualification required documents as per applicable procedures. Defines/writes User & Functional Specifications and Risk Assessment documents. Supports audit process, as required. Design test procedures and acceptance criteria with the purpose of demonstrating compliance with equipment, user and regulatory requirements while conducting Factory Acceptance Test (FAT), Installation Qualification (IQ) and Operation Qualifications (OQ) processes. Executes and collects data while conducting FAT, IQ and OQ processes. Writes related documentation. Writes Standard Operation Procedures (SOP) for the validated system/equipment. Provide training as required. Performs documents verifications and transcription checks. Manages multiples projects with multiple priorities, taking actions to meet organizational expectations. Prepares and presents business cases for capital projects. Prepares and owns change controls related to assigned projects. Uses project management techniques to identify possible roadblocks and anticipate them. Prepares/maintains own projects schedule or for those assigned to oversee. Process controls system design and specifications. Support and conducts technical investigations. Provides technical perspective during internal and external audits, regulatory inspection and due diligence. Provides technical support during process and lab equipment/system troubleshooting and process control troubleshooting. Recommends measures to improve manufacturing processes, equipment performance and quality of product Provide technical consultation services to other plant areas such as Manufacturing, Bulk Packaging, Labs, New Products, Process Support and Utilities. Backup and restore process of systems software. Access control management Support projects related to work and troubleshooting in day-to-day operations. Performs and coordinates process controls maintenance as established on the applicable procedures and as required by the GMP regulations.