Sr. Validation Software Specialist - Sterigenics U.S., LLC

The Sr. Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation. This position participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. This role reports into Corporate Quality Assurance and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations.

Duties and Responsibilities

• Authors Software Validation documents including Validation Plan, System Level Risk Assessment (SLRA), URS/FRS, IQ/CONFIG/OQ/PQ Test Protocols, Retirement Plan, Periodic Review, Data Migration Plan, Traceability Matrix, and Validation Final Report.
• Partners and communicates effectively with business customers, IT groups, management, QA, and external vendors to validate system solutions addressing compliance with SOPs, and work instructions.
• Assists Software Process and System Owners (PO and SO) to plan and manage validation projects including user acceptance testing, software periodic review and audit trail review to ensure regulatory compliance.
• Performs pre- and post-execution QC checks of user acceptance test scripts and works with SO, IT, and within QA to resolve problems.
• Validates spreadsheet, QMS, infrastructure and other IT systems.
• Manages the documentation archive (paper-based and electronic) in an inspection-ready state.
• Provides guidance to the SO, IT, and project organization regarding appropriate documentation practices and methods including creation of documentation and corrections to existing documentation.

Supervision Given

• Directly supervised by Quality Assurance Manager. There are no direct reports for this role.

Education, Experience, & Skill Required

• BS degree or equivalent experience.
• Minimum of 3 - 5 years' experience working in a regulated industry.
• Minimum of 3 years Software Validation experience.
• Knowledge and experience in gathering requirements, writing software validation documents, user acceptance testing, and working with business processes.
• Demonstrate understanding of Computer Software Assurance (CSA) vs Computer System Validation (CSV) concepts.

Training Required

• Must complete all required training for a "Quality Software Validation Specialist" outlined in the training system.

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.

VEVRAA Federal Contractor