Sterigenics
Join to apply for the
Sr. Validation Software Specialist
role at
Sterigenics 2 days ago Be among the first 25 applicants Join to apply for the
Sr. Validation Software Specialist
role at
Sterigenics Get AI-powered advice on this job and more exclusive features. Job Description
The Senior Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation. The Senior Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. The Senior Software Validation Specialist reports into Corporate Quality and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations. Job Description
The Senior Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation. The Senior Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. The Senior Software Validation Specialist reports into Corporate Quality and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations.
Duties And Responsibilities
Authoring 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 Business Process Owners (BPO), Application System Owners (ASO) and IT Infrastructure Owners (IO) to plan and manage validation projects including user acceptance testing. Performs pre- and post-execution QA checks of user acceptance test scripts and works with BPO, ASO, IO and within QA to resolve problems. Understanding of Computer Software Assurance (CSA) vs Computer System Validation (CSV) concepts. Validating spreadsheet, QMS, infrastructure and other IT systems Manages the documentation archive (paper-based and electronic) in an inspection-ready state. Provides guidance to the BPO, ASO, IO, and project organization regarding appropriate documentation practices and methods including creation of documentation, resolving deviation/defects for issues found during testing and documentation corrections. Maintains training materials and trains involved groups on software documentation and testing best practices, test coordination, and other topics as needed. CAPA Owner: Performs investigation, root cause analysis, defines Corrections/Corrective Actions and the associated Effectiveness Check. Co-auditor Internal and Software supplier audits Manages the Software Periodic Review Cycle which includes Audit Trail and User Access reviews. Other duties as assigned.
Supervision Given
Directly supervised by the Quality Assurance Manager of Software Validation. There are no direct reports for this role.
Education, Experience And Skill Required
BS Degree. 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.
Training Required
Must complete all required training for a Senior Software Validation Specialist outlined in the training system.
Pay &Benefits
Salary Range: $87,500 - $142,000 per year; depending on experience.
Sotera Health Offers a Competitive Benefits Package That Includes
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts 401(k) program with Company match that immediately vests Paid holidays, vacation and sick time Free financial planning assistance Paid parental leave Education assistance Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance Employee Assistance Program (EAP)
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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Sterigenics by 2x Get notified about new Senior Software Specialist jobs in
Oak Brook, IL . Chicago, IL $137,400.00-$233,600.00 2 weeks ago Senior Manager, Software Engineer (People Leader)
Lead Software Engineer, Rocket Travel by Agoda
Chicago, IL $148,949.00-$220,000.00 18 hours ago Chicago, IL $140,000.00-$225,000.00 2 weeks ago Sr. GoLang AND C++ Developer - Chicago, IL or Reston, VA- ONSITE (4 days a week)
Chicago, IL $126,788.71-$190,183.06 1 week ago Senior Principal - Software Asset Management (SAM)
Chicago, IL $137,400.00-$240,400.00 1 week ago Manager, Residential Portfolio Lease Admin
Senior Software Engineer, Backend - Fintech
Chicago, IL $150,000.00-$350,000.00 4 days ago Senior Software Engineer - Full Stack Java
Deerfield, IL $127,500.00-$204,000.00 3 months ago Senior Software Engineer II - Full Stack Developer
Deerfield, IL $127,500.00-$204,000.00 2 months ago Chicago, IL $110,000.00-$150,000.00 1 month ago Chicago, IL $80,000.00-$120,000.00 4 weeks ago Chicago, IL $88,000.00-$110,000.00 11 hours ago Chicago, IL $185,000.00-$235,000.00 6 days ago Chicago, IL $133,649.88-$172,958.64 1 week ago Deerfield, IL $127,500.00-$204,000.00 1 month ago Chicago, IL $180,000.00-$220,000.00 1 week ago Chicago, IL $87,200.00-$130,800.00 1 month ago Deerfield, IL $127,500.00-$204,000.00 1 month ago Senior Software Engineer (Remote) - React, Node
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Sr. Validation Software Specialist
role at
Sterigenics 2 days ago Be among the first 25 applicants Join to apply for the
Sr. Validation Software Specialist
role at
Sterigenics Get AI-powered advice on this job and more exclusive features. Job Description
The Senior Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation. The Senior Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. The Senior Software Validation Specialist reports into Corporate Quality and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations. Job Description
The Senior Software Validation Specialist analyzes system solutions and authors validation protocols, reports, and other Software Development Life Cycle documentation. The Senior Software Validation Specialist participates in the delivery of Software system solutions by assuring validation activities are conducted in a compliant and timely manner. The Senior Software Validation Specialist reports into Corporate Quality and works closely with other groups to assure the total software solution delivered meets compliance requirements and expectations.
Duties And Responsibilities
Authoring 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 Business Process Owners (BPO), Application System Owners (ASO) and IT Infrastructure Owners (IO) to plan and manage validation projects including user acceptance testing. Performs pre- and post-execution QA checks of user acceptance test scripts and works with BPO, ASO, IO and within QA to resolve problems. Understanding of Computer Software Assurance (CSA) vs Computer System Validation (CSV) concepts. Validating spreadsheet, QMS, infrastructure and other IT systems Manages the documentation archive (paper-based and electronic) in an inspection-ready state. Provides guidance to the BPO, ASO, IO, and project organization regarding appropriate documentation practices and methods including creation of documentation, resolving deviation/defects for issues found during testing and documentation corrections. Maintains training materials and trains involved groups on software documentation and testing best practices, test coordination, and other topics as needed. CAPA Owner: Performs investigation, root cause analysis, defines Corrections/Corrective Actions and the associated Effectiveness Check. Co-auditor Internal and Software supplier audits Manages the Software Periodic Review Cycle which includes Audit Trail and User Access reviews. Other duties as assigned.
Supervision Given
Directly supervised by the Quality Assurance Manager of Software Validation. There are no direct reports for this role.
Education, Experience And Skill Required
BS Degree. 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.
Training Required
Must complete all required training for a Senior Software Validation Specialist outlined in the training system.
Pay &Benefits
Salary Range: $87,500 - $142,000 per year; depending on experience.
Sotera Health Offers a Competitive Benefits Package That Includes
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts 401(k) program with Company match that immediately vests Paid holidays, vacation and sick time Free financial planning assistance Paid parental leave Education assistance Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance Employee Assistance Program (EAP)
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 Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Information Technology Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Sterigenics by 2x Get notified about new Senior Software Specialist jobs in
Oak Brook, IL . Chicago, IL $137,400.00-$233,600.00 2 weeks ago Senior Manager, Software Engineer (People Leader)
Lead Software Engineer, Rocket Travel by Agoda
Chicago, IL $148,949.00-$220,000.00 18 hours ago Chicago, IL $140,000.00-$225,000.00 2 weeks ago Sr. GoLang AND C++ Developer - Chicago, IL or Reston, VA- ONSITE (4 days a week)
Chicago, IL $126,788.71-$190,183.06 1 week ago Senior Principal - Software Asset Management (SAM)
Chicago, IL $137,400.00-$240,400.00 1 week ago Manager, Residential Portfolio Lease Admin
Senior Software Engineer, Backend - Fintech
Chicago, IL $150,000.00-$350,000.00 4 days ago Senior Software Engineer - Full Stack Java
Deerfield, IL $127,500.00-$204,000.00 3 months ago Senior Software Engineer II - Full Stack Developer
Deerfield, IL $127,500.00-$204,000.00 2 months ago Chicago, IL $110,000.00-$150,000.00 1 month ago Chicago, IL $80,000.00-$120,000.00 4 weeks ago Chicago, IL $88,000.00-$110,000.00 11 hours ago Chicago, IL $185,000.00-$235,000.00 6 days ago Chicago, IL $133,649.88-$172,958.64 1 week ago Deerfield, IL $127,500.00-$204,000.00 1 month ago Chicago, IL $180,000.00-$220,000.00 1 week ago Chicago, IL $87,200.00-$130,800.00 1 month ago Deerfield, IL $127,500.00-$204,000.00 1 month ago Senior Software Engineer (Remote) - React, Node
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr