Senior Technology Professional

AstraZeneca•Canóvanas, PR

About The Position

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.

Requirements

Bachelor’s degree in chemical, Electrical, Computer or Mechanical Engineering or other Sciences and minimum of seven (7) years related experience and/or training.
Thorough knowledge of the pharmaceutical industry with emphasis in manufacturing, packaging, laboratory, utilities and related equipment and automation.
Experience in equipment/system qualification and computer system validation covering one or more of the following areas; Plant Utilities, Manufacturing, Packaging and/or Computerized Analytical Systems.
Fully Bilingual (English and Spanish). Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports and diverse computer validation documents. Ability to write technical (both high and low level) specifications, procedures, plan, and reports. Ability to write projects proposal, plans, budgets, and business correspondence. Ability to effectively present technical information and respond to questions from group of peers, managers, and customers.
Working knowledge of MS Windows XL, 7, 10 and 11. Windows applications such as Word, Excel, Access, Power Point and Project, among others. Working knowledge of Teams, OneNote, SAP, and TrackWise.

Nice To Haves

Automation and programming skills highly desirable.

Responsibilities

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 21CFR Part 11 compliance assessment of computer systems and equipment under qualification; develops and implements corrective actions
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 subject matter expert in their area of specialization.
Be current with development in their respect area of specialization or practice.
Supports standardization of work practices and customer service performance across local, national, regional and global clients.
Actively participates providing suggestions and ideas on existing equipment/ systems optimization.
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.
Promote continues improvement in efficiency, quality, and safety through personal development, education and training
Provide technical expertise, problem solving, project management and coaching of peers and other staff.
Process engineering support on process and equipment/system design.
Actively participate/engages in outside industry and professional associations and to adopt practices favorable to AstraZeneca.