COMPUTER SYSTEM VALIDATION LEAD
Wilmington, DE
Fulltime
10+ years of experience
Must Have Technical/Functional Skill
8 10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
Familiarity with GAMP 5 and risk-based validation approach.
Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
Working knowledge of change control, deviation management, CAPA, and periodic review.
Good documentation practices; strong stakeholder management and communication skills.
Roles & Responsibilities
Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
Mentor junior CSV team members; contribute to process improvements, templates, and best practices.
...your development. Whether you're working in our four global Home Offices, Distribution Centers or Retail StoresTJ Maxx, Marshalls, Homegoods, Homesense, Sierra, Winners, and TK Maxx, you'll find abundant opportunities to learn, thrive, and make an impact. Come join our...
...He has given us. Job Summary The St. Vincent High School Spanish teacher fulfills the mission of Saint Vincent Catholic Schools... ...development of students. Job Requirements Bachelors degree and a teaching certification is required for this position. The Archdiocese...
job summary: We are looking for a senior developer to work on a global team building a core suite of applications leveraging Python and Bank's Quartz framework. Experience... ...troubleshoot the applications from a high-level. Experience in an Agile SDLC processes....
At Hamlin Bank we are a family of professionals who are committed to servicing the needs... ...for a part time to full time Teller/Bank Representative. Summary : our representatives... ...or equivalent. Minimum of 1 year experience in a cash-handling role, preferably in a...
...obtain corporate and high-income careers. We partner with large companies where students learn about careers they may not have known... ...MTV, VH1, Nickelodeon) Versace and more! We're looking for an event speaker/host who is located in the USA to work alongside a fast...