Job DescriptionPosition Summary The IT Assurance Analyst provides CSV/Assurance support for computerized systems, networks and software that have been newly installed, upgraded and/or modified to support cGMP functions in Manufacturing, Supply Chain, and Quality, as part of IT Quality and Compliance organizations. This role works closely with Change Owners to generate and support validation/assurance testing (IQ, OQ, IOQ, PQ etc.) that are compliant with Plant and Corporate policies and procedures. Responsible for reviewing, executing, documenting and approving assurance testing/validation deliverables, and if necessary, coordinate other resources in validation documents and activities.
Essential Duties & Responsibilities- Work with stakeholders to coordinate and support task execution across projects, sprints, enhancements, and incident-related work.
- Support assurance documentation per SOP (e.g., requirements, assessments, deviations, assurance plans, protocols, reports), ensuring strategies and deliverable are complete, well thought out, and aligned with assurance procedures, guidelines, external regulatory requirements, cGMP, GDocP standards, and European and International standards.
- Interact with QA, IT, Engineering and business area users to understand and identify assurance documentation content for computer system testing with emphasis on capturing appropriate system test scenarios, test cases and business requirements in testing tool.
- Execute and coordinate revalidation of computer systems.
- Assess systems and take actions for periodic review per SOP criteria.
- Review and provide feedback to plant and corporate authors on CSV guidelines, Standard Operating Procedures and policies.
- Develop and maintain a thorough working knowledge of the ICU Medical Systems assurance requirements.
- Evaluate routine activities to recommend and support process efficiency enhancements.
- Perform other related duties as assigned or required, including extended work schedules when required to meet deadlines.
Knowledge & Skills- Working knowledge of Oracle Agile PLM and Oracle EBS required
- Working knowledge of data migration and sampling methods preferred
- Process improvement training preferred.
- Resourcefulness and problem-solving skills, with the ability to navigate identify inefficiencies and ambiguity, remove obstacles, and deliver outcomes through innovative, forward-thinking planning needed.
- Experience in one of the following disciplines required: Quality, Manufacturing, Facilities/utilities, Pharma/Solution processes, Sterilization, IT Applications and/or Controls systems/software.
- Experience and functional knowledge of Good Automated Manufacturing Practice (GAMP), cGMP, SDLC, Risk Assessment, EU Annex 11, ISO 13485 and/or 21 CFR Part 11 Electronic Records and Electronic Signatures needed.
- Good organizational, presentation, meeting facilitation, and technical writing skills required.
- Attention to details and the ability to proofread and audit validation documents required.
- Familiarity with automation tools preferred.
Minimum Qualifications, Education & Experience - Must be at least 18 years of age.
- Bachelor's degree in Computer Science, Information Systems, Engineering, or a related field from an accredited college or university is required.
- Experience in ERP systems development, change, implementation, and lifecycle management - preference to Oracle EBS and Agile 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.
- Experience working with SOX, Data Privacy and Security requirements a plus.
- Ability to collaborate and communicate with a variety of key stakeholders (IT, Manufacturing, Quality, Supply Chain, Logistics, Finance, Internal Audit)
- Familiarity with Test Management tool (e.g., ValidationMaster), MS Excel and/or SQL queries preferred.
- Demonstrable experience of working well in a dynamic, demanding environment with minimal supervision and high resourcefulness.
- Demonstrable experience in balancing multiple priorities and delivering timely, high-quality outcomes.
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.
