CS Validation Analyst III
Location: Bonita Springs
Posted on: August 21, 2020
Requisition ID: 45740 Title: CS Validation Analyst III Division:
Arthrex, Inc. (US01) Location: Bonita Springs, FL
Be part of an ever growing, dynamic company in the Medical Device
industry. We have great benefits, tremendous opportunities, and a
fantastic people-oriented culture. Work with extremely talented
co-workers and accomplished business leaders while ensuring our
computer systems are fully validated and fulfill the needs of our
business. Competitive compensation and benefits, including a
generous bonus program is waiting for you in sunny Naples,
Support computer system validation activities at Arthrex.
Essential Duties and Responsibilities:
--- Ensure appropriate regulations, such as 21 CFR Part 11, 820 and
cGMP regulations, are addressed in validation.
--- Coordinate, assist and document validation activities;
preparation/approval of protocols and reports.
--- Draft, review and approve local validation and compliance
documents supporting GxP computerized systems, and relevant
infrastructure, including those related to system procurement,
audit, performance, compliance evaluation, and validation. Examples
include SOPs, qualification protocols, gap assessments, risk
assessment, Impact Assessment, user requirements, functional and
configuration specifications, requirements traceability, validation
plans, validation summary reports and change controls.
--- Prepare, assist, or participate in system design, specification
development, and design review.
--- Perform systems FDA validation for SAP and customizations.
--- Perform revalidation and change control validation related
--- Ability to apply complex system validation principles to work
--- Must be able to function independently, play a leadership role
within a cross-functional team and address a variety of moderate to
--- Assess the impact of system changes thru change management and
change control systems; participate in the planning and
implementation of change.
--- Provide training to colleagues and contractors on our approach
to systems implementation and validation SOP's.
--- Assist validation activities of cross functional teams that
include technical functions such as Information Systems,
Manufacturing and QA Engineering, business owners.
--- Develop and maintain Validation SOPs, forms, documentation and
- Coordinate meetings, document issues, action items, meeting
notes, do appropriate follow up related to CSV projects. Recommend
enhancements to project specs
- Coordinates fulfillment of all requirements for systems
- Project Management and mentorship of junior-level analysts
Education and Experience:
- Bachelor's degree in computer science, technology or related
- At least five years experience in experience in the validation
of computer systems, manufacturing, packaging, equipment and
process, as well as utilities, and facilities
- Must have thorough understanding of FDA regulations and
computer validation guidance documents
- FDA Compliance experience required
Knowledge and Skill Requirements/Specialized Courses and/or
- Experience in thorough testing of applications, computerized
systems, changes and implementations.
- Familiarity with the following systems: MES, SAP, ERP, Document
Management, HP Quality Center and Quality Records
- Familiarity with GAMP and other approaches to System
Development Life Cycles (SDLC), CAPA.
- Computer knowledge of 21 CFR Part 11, CFR 820Excellent
communication skills and customer service orientation
Machine, Tools, and/or Equipment Skills:
PC servers, workstations and laptops. Microsoft environment. Work
with standard current computer applications, such as word
processing, spreadsheets and data bases.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, age, sex, sexual
orientation, gender identity, national origin, disability or
protected veteran status.
Nearest Major Market: Fort Myers
Nearest Secondary Market: Cape Coral
Developer, Medical, Engineer, ERP, Information Systems, Technology,
Keywords: Arthrex, Bonita Springs , CS Validation Analyst III, Professions , Bonita Springs, Florida
Didn't find what you're looking for? Search again!