Junto HLS has been engaged by a Top 20 pharma client to recruit a Principal Validation Engineer – Computerized Systems.
- Provide leadership in scheduling, planning and execution of validation projects for site based computer systems.
- Define validation strategies and oversight through the implementation of validations plans for site based computer systems.
- Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems.
- Supports the validation of plant automation and process control systems, along with QC laboratory and Desktop based business and analytical systems.
- Sound industry knowledge, project proficiency, and autonomy expected. Considered a validation Subject Matter Expert (SME) in the areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU’s Annex 11, and GAMP® 5 requirements.
- Plan computer validation projects and track execution of validation activities versus project timeline. Manage and plan the work of the internal and contract resources.
- Perform change control assessments and write/review validation plans, qualification protocols and summary reports. Manage the execution of qualification protocols and review test results.
- Mentor junior staff in their job performance and project related activities.
- Support development of best demonstrated validation practices within the validation department, based on current industry practices and regulatory guidelines.
- Develop, complete, log and archive computer systems validation documentation.
- Greater Minneapolis, MN
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.