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Computer Systems Validation Engineer

Job Highlights

  • Experience in computer system compliance, testing, validation (CSV) activities
  • Knowledge and experience in Pharma GMP regulations
  • Proficient in written and spoken English

A dynamic role in an exciting team who implement critical software systems. As a CSV Engineer you will be focused on ensuring the quality of computer systems used in the Pharmaceutical and Lifescience industries. We qualify and validate both internally developed software, and solutions that are used by our customers to manage data and produce medicine. The role will participate in Computer Systems Validation projects to ensure systems are compliant with international GMP regulations, both in Thailand and globally.

 

Duties and Responsibilities

  • Participate in customer validation projects and workshops, communicate and co-ordinate with customer to deliver project
  • Learn best practices for computer systems validation and international standards for IT systems quality and compliance
  • Identify and assess computer systems which impact cGMP operations using a risk based methodology
  • Author / review CSV documentation such as validation plans, requirements, specifications, assessment, test protocols, test reports, and validation reports.
  • Lead assigned Computer System Validation (CSV) activities with support from senior team members and experts
  • Work closely with Validation Manager and QA Compliance to ensure appropriate validation of cGMP computer systems.
  • Support execution of validation plans and validation documents if requires.
  • Initiate, prepare and closeout all CSV related deviations, discrepancies and change control documents.
  • Develop CSV procedures for customers’ use and maintenance in GxP operations and provide training as necessary.
  • Learn how to train and support clients learning on CSV and related topics such as DI.
  • Ensure that all documentation and services are delivered on time with quality and are aligned with standards and best practices.
  • Other related duties as assigned.

 

Knowledge/Experience/Qualifications

  • Bachelor’s degree or higher in relevant field (e.g. engineering, computer science, biotechnology, pharmacy, etc.)
  • Experience in computer system compliance, testing, validation (CSV) activities in a regulated environment or other demonstrable practical knowledge and exposure.
  • Knowledge and experience in Pharma GMP regulations and best practicessuch as GMP PIC/S, Annex 11, GAMP, Data Integrity, and risk-based approaches to validation.
  • Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ], Reports, Trace Matrices, SOPs, etc.).

 

Personal Skills and Attributes

  • Ability to work independently with the guidance of experienced seniors and work collaboratively in a client focused environment.
  • Strive to learn and improve approaches to CSV and software quality
  • Be highly motivated, organized, and capable of managing priorities.
  • Have the ability to work with multiple clients and handle various projects.
  • Responsible and good team player able to work efficiently to deadlines and high-quality standard.
  • Have excellent communication, presentation, and interpersonal skills.
  • Meticulous in performing reviews of technical documentation (English).
  • Able to travel domestically and internationally.

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+66 2630 4525




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