IT Specialist III, GMP Systems

What You’ll Do
- Deploy, support, and troubleshoot end-user devices (laptops, workstations, printers, tablets, phones, audio/video).
- Configure, deploy, and support GMP systems in manufacturing facility or laboratory environments.
- Serve as System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 GMP environment.
- Partner with Business Process Owners on upgrade/patching and system changes to ensure GMP compliance.
- Follow Computerized Systems Validation (CSV) processes to build out and qualify/validate GxP systems.
- Author IT validation documents (SDCS, IQ, backup/restore protocols, system administration procedures).
- Provide SME/system owner input for validation documents (User/Functional Requirements, Risk Assessments, Operational Qualification).
- Support Quality Change Management activities and impact assessments.
- Implement IT tools (Windows NTFS permissions, Active Directory, Group Policy) to meet data integrity and regulatory requirements.
- Coordinate with vendors for troubleshooting/resolution.
- Create user accounts in applications per administration procedures.

Who You Are
- Bachelor’s or technical institute degree in Computer Science, Information Systems, or science-related field; or equivalent experience.
- 5+ years in Biotech/Pharma supporting critical manufacturing systems.
- Biopharmaceutical manufacturing domain experience.
- Experience as System Owner for validated GxP systems.
- Familiarity with Data Integrity methodologies.
- Experience writing SOPs.
- Basic knowledge of MES, DeltaV, LIMS, data historian, ERP.
- Knowledge of GMP, Health Authority practices, 21 CFR Part 11, cGMP Annex 11, and Data Integrity principles.

Application Instructions
- Apply today.