Specialist II, Software Validation

Position Overview

Responsible for preparing and executing test documentation for computerized systems that affect regulatory compliance and non-regulatory processes based on MicroVention’s Quality Management System (QMS) procedures. Job duties:
  • Assist the business or process owner to complete and seek approval for software change requests.
  • Create or modify software requirement specifications to include applicable user/functional requirements for a system change.
  • Write test scripts for testing scenarios and define test plans for execution.
  • Develop software validation protocols (IQ, OQ, PQ) to verify if the system is compliant with regulatory and business requirements.
  • Perform dry run or other testing processes with functional/technical resources to uncover issues before formal validation begins.
  • Review and create validation reports to summarize results to include defects or issues during the test execution.
  • Manage completion of projects per software validation master plans and ensure timely completion. Maintain frequent communication with stakeholders and managers regarding project status.
  • Work with internal/external validation resources to guide them on company procedures and key business processes on the software being tested.
  • Develop software validation procedure(s) as needed to ensure alignment with appropriate regulatory requirements. This includes, but is not limited to, SOPs, work instructions company forms, risk assessment procedures, change control documents, etc.
  • Ensure software lifecycle program complies with applicable regulatory requirements including requirements for electronic records and electronic signatures.
  • Review and approve software validation protocols and reports (e.g., verify that test cases are adequate, verify executed protocols for GDP, etc.)
  • Demonstrate effective communication style working with all levels of organizational structure through multiple departments and across global sites.
  • Provide software training to users within the organization after receiving training from the implementation vendors.
  • Question current methods while evaluating continuous improvement on validation processes and procedures.
  • Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
  • Perform additional duties as assigned.

Job Details

Job ID 11641BR

Aliso Viejo, California, USA

Salary Range:

$69,145 - $96,802 (Compensation could be higher based on education, experience and skill sets)

    1. Bachelor’s degree in IT, Engineering, or other relevant discipline, or equivalent combination of education and experience.
    2. Minimum three (3) years of work experience validating manufacturing-related (both GxP and non-GxP) and IT software applications.
    3. Experience with successfully managing/executing validation projects with the ability to motivate cross-functional teams to complete their assigned tasks.
    4. Experience with working independently, effectively, and confidently in a team environment.
    5. Strong written and verbal communication and time management skills.
    6. Experience with software regulations, including involvement with electronic records and electronic signatures.
    7. Experience with Software Development Life Cycle of controlled systems.
    8. Demonstrated experience in medical device Manufacturing software and Quality Management software.
    9. Working knowledge of General Principles of Software Validation; Final Guidance for Industry and FDA Staff (GPSV).
    10. Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11.
    11. Proficient with Microsoft Office suite of applications.
    Desired Qualifications
    1. Ability to manage the software validation lifecycle from software change requests to software change releases.
    2. Excellent knowledge of medical device software regulations, including requirements for electronic records and electronic signatures.
    3. Understanding of a computer system and manufacturing validation processes.
    4. Able to work independently and with minimal guidance to perform required tasks.
    5. Ability to translate GxP compliance requirements into practical validation plans.
    6. Ability to work with multiple associates and prioritize projects to meet deadlines.
    7. Ability to document complex procedures and troubleshooting procedures related to systems.
    8. Working knowledge of Windchill PLM, SAP, and MES systems.
    9. Proficient with Microsoft Office suite of applications