Sr Computer Systems Validation Analyst
On-siteClayton, North Carolina, United States
Job Summary
Conduct subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. Participate in all IT solutions validation activities for Infrastructure, Systems, and Equipment supporting Laboratories, Manufacturing, and Business Areas. Facilitate, review, approve, and develop validation deliverables including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols. Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies. Provide guidance and support to project teams on validation and qualification requirements while continuously monitoring and improving documentation and processes. Perform assigned Quality Systems activities including Document Management, Change Control, Deviations, and CAPA's. Participate as a CSV SME in audits and inspections to demonstrate validated state and release to use. Coach and mentor personnel, develop training programs, and execute project activities using cLEAN tools for visual management. Collaborate with cross-functional teams to ensure IT solutions meet business needs, are delivered on time, and are properly documented.
Required Qualifications
- Bachelor's Degree in IT, Engineering, Science, or relevant field of study from an accredited university
- Minimum of seven (7) years of experience in IT compliance
- Minimum of five (5) years of experience on Validation and Testing of IT Solutions
- Excellent writing and communication skills, in English
- Excellent customer service skills and ability to collaborate effectively in a team environment
- Excellent problem solving, negotiation, conflict management, and interpersonal skills
- Excellent planning, organizing, decision making and deal with complexity and ambiguity
- Strong computer skills and MS Office Expert
- Ability to move equipment &/or supplies weighing up to 33 pounds within the facility
- Ability to be on your feet for up to 12 hour shift
- Corrected vision to 20/20 or 20/25 based on role
- Color vision based on role
- Ability to work in loud noise environments with hearing protections
- Ability to work in an open office environment with the possibility of frequent distraction
- Ability to travel up to 10% of the time
Desired Qualifications
- Master's degree in IT, Engineering, Science, or relevant field of study from an accredited university
- Certified Software Quality Engineer (CSQE)
- COBIT Certification
- Lean Six Sigma Green Belt or Black Belt
- Experience with electronic application lifecycle software, from requirements gathering to testing and deployment, preferrable HP ALM preferred
- Experience as SME participating in Audits and Inspections
- Experience on GxP, change management and deviation handling
- Experience with Incident, Problem, and Change Management in IT
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