Qualification Lead - IT/OT
About The Position
The Qualification Lead is responsible for qualifying OT systems and managing quality for IT and OT systems. The role ensures required validation and qualification deliverables are implemented in accordance with the Customer Quality Manual and applicable regulatory requirements. The lead authors, reviews, and/or approves deliverables under Customer procedures and assesses supplier-provided deliverables for compliance with Customer requirements. The role leads project test resources for validation and qualification activities, represents project quality for testing activities in engagement with local site QA and/or QA eCPL, reports quality activity status to key stakeholders, and advises suppliers on completing supplier-provided validation and qualification deliverables appropriately. Activities include qualifying IT/OT systems; authoring, executing, and reviewing URS, FS, IQ, OQ, and test protocols in Kneat; test execution, troubleshooting, and defect resolution; coordinating with QA, PCM, ITOT teams, and suppliers; and participating in FAT, SAT, commissioning, and startup.
Requirements
- Strong CSV/CQV experience.
- Background in GMP-regulated pharmaceutical manufacturing.
- Knowledge of GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Experience with PLC, SCADA, DCS, MES, Historian, and IT/OT systems.
- Hands-on IQ/OQ/PQ execution and FAT/SAT support.
- Experience with Kneat, ValGenesis, Veeva Vault, TrackWise, ServiceNow, or similar validation platforms.
Responsibilities
- Qualify IT/OT systems in accordance with the Customer Quality Manual and relevant regulatory requirements.
- Author, review, and/or approve validation and qualification deliverables according to Customer procedures.
- Review and approve supplier-provided validation and qualification deliverables and verify their compliance with Customer requirements.
- Lead project test resources for validation and qualification activities.
- Represent project quality in testing activities and engage with local site QA and/or QA eCPL.
- Report the status of quality-related activities to key stakeholders.
- Advise suppliers on the appropriate completion of supplier-provided validation and qualification deliverables.
- Author, execute, and review URS, FS, IQ, OQ, and test protocols in Kneat.
- Perform test execution, troubleshooting, and defect resolution.
- Coordinate with QA, PCM, ITOT teams, and suppliers.
- Participate in FAT, SAT, commissioning, and startup activities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
