IT Specialist III, GMP Systems

Responsibilities:
- Deploy, support, and troubleshoot end user devices (laptops, workstations, printers, tablets, phones, audio/video).
- Configure, deploy, and support GMP systems in manufacturing or laboratory environments.
- Serve as System Owner for Manufacturing IT Applications and/or QC Analytics systems in a 24x7 GMP environment.
- Coordinate upgrades/patching and system changes with Business Process Owners to ensure GMP compliance.
- Follow Computerized Systems Validation (CSV) processes to build and qualify/validate GxP systems.
- Author IT validation documents (SDCS, IQ, Backup Configuration/Restore Protocols, System Administration Procedures).
- Act as SME/System Owner for validation documents (User/Functional Requirements, Risk Assessments, Operational Qualification).
- Document Quality Change Management activities and provide impact assessments.
- Implement IT tools (Windows NTFS permissions, Active Directory, Group Policies) to meet data integrity and regulatory requirements.
- Contact vendors for troubleshooting and issue resolution.
- Create application user accounts following administration procedures.

Qualifications/Requirements:
- Bachelor’s (or technical institute) in CS, Information Systems, or a science-related field; or equivalent work experience.
- 5+ years in biotech/pharma supporting critical manufacturing systems.
- Biopharmaceutical (or similar) manufacturing domain experience.
- Experience as System Owner for validated GxP systems.
- Familiar 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.