IT Systems Assurance Analyst, Manufacturing/Custom Apps - (remote)

Job Title

IT Systems Assurance Analyst, Manufacturing/Custom Apps

FLSA Status

Exempt

Work Arrangement

Job opening is fully remote. Can be performed from any state within United States with exception of CA, CO, CT, ME, MT or NY.

Position Summary

This position is responsible for IT Quality Assurance, Computer System Validation, Configuration of Manufacturing and Custom applications/solutions that are developed/deployed by ICU Medical IT. This role will require thorough knowledge of Software Quality Assurance and Computer System Validation functions and will act as SME for custom developed applications supporting Manufacturing, Quality and Supply Chain operations in a heavily regulated environment. This position is within the Global IT Systems Assurance team and will be working to deploy/enhance streamlined, efficient, compliant SDLC deliverables. **

Essential Duties & Responsibilities

• Perform regulatory/ compliance/ risk assessment on IT systems changes in relation to GxP, SOX, Data Integrity, Policies/ SOPs
• Partner closely with IT and business functions to identify and document business requirements and prioritization.
• Ensure Validation Plans and strategies are in alignment with validation policies, procedures and guidelines and external regulatory requirements, and European and International standards.
• Create appropriate system test scenarios, test cases in compliance with regulatory guidelines.
• Coordinate testing/ execution of changes/ enhancements with the business to ensure successful delivery of changes, deviation/ issue management and effective reporting
• Ensure validation packages contain all relevant information, rationales, references, and data to support the change, and verify that all reports and protocols are reviewed and approved as appropriate.
• Maintain a thorough working knowledge of the ICU Medical IT Policies, Quality Systems and Validation requirements.
• Perform other related duties as assigned or required, including work extended schedules when required to meet deadlines.
• Support test automation effort.

Knowledge & Skills

• Experience in ERP systems development, implementation, and lifecycle management – prefer Oracle EBS.
• Experience in Manufacturing Execution Systems development life cycle.
• Experience working with home-grown, custom/ bespoke applications.
• 4+ years of experience in Computer System Validation/ testing in one of the following – Manufacturing, Lab/Facilities, Pharma/Solution processes, Sterilization, Controls systems.
• Familiarity with regulatory requirements related to 21 CFRs - Part 11, 820, 210/211, EU Annex 11 and ERES/ Data Integrity requirements.
• Nice to have: Experience working with SOX, Data Privacy and Security requirements.
• Must have good organizational, presentation, meeting facilitation and technical writing skills.
• Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit)
• Familiarity with SQL queries, MS Excel, ALM/Test Management tool and Automated testing (ex Ranorex/ UFT).
• Experience with Agile and Waterfall SDLC.
• Works well in a dynamic, fast-paced environment with minimal supervision and high resourcefulness.
• Ability to balance multiple priorities and deliver timely, and high-quality end work product.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• Bachelor’s degree from an accredited institution in Computer Science, Information Systems or STEM field
• 4+ years of experience in a BSA/ BA/ QA/ Validation role

Work Environment

• This is largely a sedentary role.
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel less than 5% of the time.

This role is based remotely: the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Governance & Risk **

Primary Location**

US-United States - Remote - USA **

Schedule**

Full-time **

Shift**

Day Job