Global Quality Junior CSV Engineer

Uniphar Group-posted 5 days ago
Full-time • Entry Level
Remote • Gloucester Point, VA
1,001-5,000 employees
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Global Quality Junior CSV Engineer Full Time Permanent Remote The Role To contribute to project workstreams across core functions such as sales, commercial operations, procurement, and planning on a global scale. This position offers a CSV engineer the opportunity to play a pivotal role within a major business transformation programme, engaging with projects that impact the organisation worldwide.

  • Assist in the development, implementation, and maintenance of Computer System Validation (CSV) documentation in compliance with regulatory requirements and Good Practice (GxP) standards.
  • Support the validation of computerized systems across the company.
  • Participate in risk assessments and impact analyses for new and existing computer systems.
  • Collaborate with cross-functional teams such as Operational Quality, IT, Operations, Project Management and Test teams to ensure systems meet user requirements and regulatory guidelines.
  • Assist with deviation investigations, change controls, and corrective and preventive action (CAPA) processes related to CSV activities.
  • Remain up-to-date with the latest regulations, guidance documents, and industry best practices related to CSV and governing regulations.
  • Support audits and inspections by providing relevant CSV documentation and expertise.
  • Support the delivery of CSV projects with basic project management skills.
  • Support the delivery of a global CSV plan in collaboration with Business, Technology and Quality teams.
  • Contribute to the continuous improvement of CSV processes.
  • Promote a culture of quality excellence that encourages ethical conduct and commitment to compliance.
  • This role will involve some international interaction and some international travel.
  • Suitable for Graduate with Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related discipline.
  • Familiarity with GxP regulations (GMP, GDP, GCP, etc.) and their impact on computerised systems.
  • Excellent written and verbal communication skills, with the ability to produce clear and concise technical documentation.
  • Strong analytical and problem-solving abilities.
  • Ability to work both independently and collaboratively within a team environment.
  • Attention to detail and a commitment to maintaining high-quality standards.
  • Previous experience (e.g., internship, placement, or project) in a pharmaceutical or regulated environment.
  • Knowledge of software development lifecycles, IT infrastructure, or data integrity principles.
  • Understanding of risk management and change control processes.
  • Familiarity with audit processes and regulatory inspections.
  • Proficiency with electronic systems such as document management systems, SDLC management systems, testing systems.
  • Strong organisational skills with the ability to manage multiple tasks and priorities.
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