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 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 changes to ensure GMP compliance.
- Follow Computerized Systems Validation (CSV) process to build, qualify, and validate GxP systems.
- Deploy and author validation documents (SDCS, IQ), Backup Configuration and Restore Protocols, and System Administration Procedures.
- Act as SME/System Owner for validation documentation (User/Functional Requirements, Risk Assessments, Operational Qualification).
- Support Quality Change Management documentation and impact assessments.
- Implement IT tools (Windows NTFS permissions, Active Directory, Group Policies) to meet data integrity and regulatory requirements.
- Coordinate with vendors for troubleshooting and resolution.
- Create user accounts in applications per administration procedures.

Qualifications / Skills:
- 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 (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 (e.g., DeltaV), LIMS, Data Historian, ERP.
- Knowledge of GMP, Health Authority practices, 21 CFR Part 11, cGMP Annex 11, and Data Integrity principles.

Application:
- Apply today.