Senior Technology Professional

Overview

Technical Lead on 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. Coordinates and conducts 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 IPR/AZ procedures and guidelines. Provides leadership and advance professional technical guidance in field of expertise to the organization.

• 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.
• Makes 21
  
  CFR Part 11 compliance assessment of computer systems and equipment under qualification; develops and implements corrective actions
• IPR’s Project management:
• Manages multiples projects with multiples priorities, taking actions to meet organizational expectations.
• Supports all aspects of a project, including, but not limited to new technology acquisition, new product/package introduction, process development and optimization.
• Uses meeting techniques to present projects status, establish priorities and presents resources utilization logistics.
• 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.
• Prepares outside contractor scope of work and submit them to supervisor.
• Oversees contractor’s activities within her/his projects, as required.
• Deal with roadblock situations and ensure that any problems can be resolved expeditiously, either within IPR or in conjunction with the Vendor.
• Coordinates inter-departmental efforts to achieve projects success.
• Attends project relevant meetings representing their area, as required.
• Reports projects progress and discuss relevant issues and propose alternative to solve those issues.
• Write and execute commissioning, and start-up documentation.
• Process controls system design and specifications.
• May serve as primary point of contact between their area and project leader.
• Able to influence project teams and recommend scientifically rigorous, risk management solutions to technical challenges.
• Develops and maintains robust relationship with key vendors.
• Works closely with colleagues, PETs and the rest of the project team to ensure projects activities progress smoothly and up to the completion of the hand over the process run robustly.
• Responsible for evaluation and utilization of new technology for pharmaceutical processes and equipment optimization both for new and existing products.
• Evaluate and implement Process Analytical Technologies (PAT) Systems to optimize/support pharmaceutical process units and laboratory applications.
• Promotes and develops excellence in problem solving techniques
• Leads and conducts technical investigations.
• Provides technical perspective during internal and external audits, regulatory inspection and due diligence.
• Acts as a…