Computer System Validation Engineer
Emergent BioSolutions
- Baltimore, MD
- Permanent
- Full-time
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Possess strong knowledge of validation and related practices, including governmental regulations (e.g. 21CFR Part 11, EU Annex 11)
- Plan, coordinate, and execute assigned projects by effectively using Project Management methodologies
- Subject matter expert on computer validation lifecycle process and ability to clearly articulate the process and systems at the plant to client and regulatory bodies
- Validating/qualifying computerized manufacturing PLC-based and Windows-based systems operating in GXP environment and ensuring data integrity
- Write and review computer system validation and data integrity documentation including:
- Validation Plans
- User Requirements
- IQ/OQ/PQ Protocols
- Part 11 Gap Analyses
- Trace Matrix
- Validation Summary Reports
- Periodic Reviews of computer systems
- Configuration specifications
- Perform global computerized system risk assessments
- Perform computerized system vendor evaluations
- Represent Camden/MDCW on global project teams
- Manage contractors assisting with CSV activities at Camden/MDCW
- Represent CSV on data integrity teams
- Act as a coach and mentor to other members of EFV and project teams to drive continuous improvement, knowledge transfer, and professional growth of self, as well as colleagues
- Determines own instructions and procedures on day-to-day tasks and new assignments
- Drive the complete execution of assigned projects in a manner that drives high engagement from project team members
- Bachelor's degree required
- The ideal candidate will have at least 7 years of experience in computer systems validation and 21 CFR Part 11 / Annex 11 in a GMP or GLP regulated industry.
- Comprehensive knowledge and experience on computer validation lifecycle process.
- Experience with SAP, PLCs and laboratory computer systems used in GMP and/or GLP environment
- Basic skills and fluency in Microsoft Word, Outlook and Excel