IT Specialist III, GMP Systems
Evotec
21 days ago
On-site
Redmond, WA
IT
Responsibilities:
- Deploy, support, and troubleshoot end-user devices (laptops, workstations, printers, tablets, phones, audio/video).
- Configure, deploy, and support GMP systems in manufacturing facility/lab environments.
- Serve as System Owner for Manufacturing IT Applications and/or QC Analytics in a 24x7 GMP environment.
- Coordinate with Business Process Owners on upgrades/patching/changes to ensure GMP compliance.
- Follow Computerized Systems Validation (CSV) to qualify/validate GxP systems.
- Author IT validation documentation (SDCS, IQ, Backup/Restore Protocols, System Administration Procedures).
- Act as SME/System Owner for validation documents (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/regulatory requirements.
- Contact vendors for troubleshooting.
- Create user accounts per administration procedures.
Qualifications & Skills:
- Bachelor’s or technical institute degree in CS/IS/science (or equivalent experience).
- 5+ years in biotech/pharma supporting critical manufacturing systems.
- Biopharmaceutical (or similar manufacturing) domain experience.
- System Owner experience for validated GxP systems.
- Data Integrity methodologies; SOP writing experience.
- Basic knowledge of MES, DeltaV, LIMS, Data Historian, ERP.
- Knowledge of GMP/health authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
Benefits:
- Base pay $115,000–$126,500; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; life insurance; 401k match; flexible work; paid time off/holidays; wellness/transportation benefits.
Application:
- Apply today.
- Deploy, support, and troubleshoot end-user devices (laptops, workstations, printers, tablets, phones, audio/video).
- Configure, deploy, and support GMP systems in manufacturing facility/lab environments.
- Serve as System Owner for Manufacturing IT Applications and/or QC Analytics in a 24x7 GMP environment.
- Coordinate with Business Process Owners on upgrades/patching/changes to ensure GMP compliance.
- Follow Computerized Systems Validation (CSV) to qualify/validate GxP systems.
- Author IT validation documentation (SDCS, IQ, Backup/Restore Protocols, System Administration Procedures).
- Act as SME/System Owner for validation documents (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/regulatory requirements.
- Contact vendors for troubleshooting.
- Create user accounts per administration procedures.
Qualifications & Skills:
- Bachelor’s or technical institute degree in CS/IS/science (or equivalent experience).
- 5+ years in biotech/pharma supporting critical manufacturing systems.
- Biopharmaceutical (or similar manufacturing) domain experience.
- System Owner experience for validated GxP systems.
- Data Integrity methodologies; SOP writing experience.
- Basic knowledge of MES, DeltaV, LIMS, Data Historian, ERP.
- Knowledge of GMP/health authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles.
Benefits:
- Base pay $115,000–$126,500; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; life insurance; 401k match; flexible work; paid time off/holidays; wellness/transportation benefits.
Application:
- Apply today.