Computer System Validation Specialist

3 weeks ago


Morrisville, Pennsylvania, United States Inizio Engage Full time

Job Description:

The Computer System Validation Specialist will be responsible for generating and executing validation protocols and reports in line with GxP, industry best practices, and company policies. This role will also involve acting as a test lead for non-GxP systems, preparing test protocols and reports as required.

About the Role:

  • Responsible for generating and executing validation protocols and reports.
  • Support IT COE with assessment of all new global IT projects to ensure GxP requirements are understood and agreed at project initiation phase.
  • Generate validation protocols, testing protocols, reports, and procedures generated by the company or external vendors.
  • Manage the testing process for Cloud-based platforms and report progress to respective project leads and CSV Lead in a timely manner.
  • Support client audits, internal audits, and regulatory inspections as CSV subject matter expert.
  • Safeguard patient privacy and confidentiality by following the guidelines set forth in the Privacy and Security Rules of the Health Insurance Portability and Accountability Act (HIPAA).

Requirements:

  • Bachelor's Degree or related work experience required.
  • At least 1-3 years of experience in a direct CSV role required.
  • At least 2 years of experience in a regulated environment required.
  • Working knowledge in creating test protocols for Salesforces in a regulated environment.
  • Experience delivering CSV projects within the healthcare industry.
  • Experience in working with a structured Project Management Office (PMO) to deliver projects to industry best practice.
  • Good knowledge of GAMP.
  • Good working knowledge of Annex 11 and 21CFR Part 11.
  • Good knowledge of business enterprise computer systems.
  • Experience working with hardware and software in a controlled (qualified) environment.
  • Experience with Pharmaceutical Quality Systems including change control, deviation, CAPAs, and document management (GDP).
  • Team player with the ability to communicate across functional departments and divisions.
  • Project management, process design experience.
  • Ability to challenge the status quo and propose process improvements.
  • Highly motivated.
  • Critical thinking and problem-solving skills.
  • Strong organizational skills, detail-oriented with the ability to multitask in a very fast-paced environment.
  • Exceptional written and verbal communication skills.
  • High computer proficiency with the Microsoft Office package, consisting of Outlook, Word, Excel, and PowerPoint. Microsoft Visio and/or Adobe Acrobat experience a plus.

Benefits:

  • Competitive compensation: $85,000 - $110,000 per year.
  • Excellent benefits, including accrued time off, medical, dental, vision, 401(k), disability & life insurance, paid maternity and bonding time benefits, employee discounts/promotions.
  • Generous performance-driven Incentive Compensation package.
  • Competitive environment with company-wide recognition, contests, and coveted awards.
  • Exceptional company culture.
  • Recognized as a Top Workplace USA 2021.
  • Awarded a 'Great Place to Work' award in 2022 and 2023.
  • Fortune Best Workplaces in Biopharma 2022.


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