Computer System Validation Technologist

1 week ago

Pickering, Ontario, Canada Nanz Pharma Full time

Company Description

Nanz Pharma is a globally respected pharmaceutical organization committed to innovation, excellence, and community service. We aim to improve lives with our hygiene and wellness products and strive to be a global leader in the field. Our vision is to provide high-quality products at affordable prices, fostering trust, quality, and brilliance with our customers, partners, and employees.

Role Description

A
Computer Systems Validation (CSV) Technologist
plays a crucial role in ensuring that computer systems, equipment, and software used in regulated industries (such as pharmaceuticals, biotechnology, and manufacturing) meet regulatory standards and consistently operate as intended. This includes planning, executing, and documenting validation activities in compliance with cGMP, GxP, FDA 21 CFR Part 11, GAMP 5, EU Annex 11, and other relevant standards to safeguard data integrity and system reliability.

Job Responsibilities

  • Develop and execute validation protocols for computerized systems, including systems for manufacturing, laboratory, and enterprise operations.
  • Draft and maintain clear, concise validation documentation: Validation Plans, Requirement Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Summary Reports.
  • Conduct formal testing of functional, system, and regulatory requirements in accordance with approved protocols.
  • Assist with validation projects and ensure effective communication of project milestones and timelines.
  • Adhere to pertinent regulatory requirements and company policies, including SOPs, safety, and data integrity protocols.
  • Collaborate with system owners, IT, QA, vendors, and cross-functional teams to align validation activities.
  • Participate in design reviews, audits, and periodic assessments to maintain the validated state throughout the system lifecycle.
  • Propose and implement process improvements and efficiency enhancements.
  • Provide training and support to staff on CSV processes and regulatory requirements.
  • Support change control processes related to computerized systems.
  • Maintain proficiency in current regulatory updates, validation methodologies, and industry best practices.

Job Requirements

  • Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field.
  • 2+ years of experience in CSV or a similar regulated environment.
  • Strong knowledge of regulatory standards: FDA 21 CFR Part 11, GxP, cGMP, GAMP 5, and EU Annex 11.
  • Understanding of computer system/software development life cycles and risk-based validation.
  • Excellent technical writing, documentation, and project management skills.
  • Strong analytical and problem-solving abilities with high attention to detail.
  • Ability to work independently and collaboratively in team environments.

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