Validation Engineer
Ascential Technologies
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- Pay
- $90K to $105K
- a year
- Location
- Ham Lake, MN
- Work style
- On-site
- Job type
- Full time
- Posted
- Nov 6
- 2 days ago
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About the company
Ascential Technologies
Industrial automation · 51 to 200 employees
What you'll do
- Manage qualification and validation activities for facilities, equipment, instruments, systems, and software
- Author and approve validation master plans, protocols (IQ/OQ/PQ), and summary reports
- Oversee and execute validation protocols, ensuring accurate data collection and analysis
- Ensure validation activities comply with FDA, EU, ICH, ISO and relevant standards
- Conduct and lead risk assessments (e.g., FMEA) and implement mitigation strategies
- Manage requalification and revalidation activities following changes, upgrades, or reviews
- Maintain validated state documentation and change control records
Key skills
equipment validationasset lifecycleIQ/OQ/PQvalidation master plansdata collection and analysisFDAEUICHISOFMEArisk assessmentschange control
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Asset Lifecycle and Validation Program
Support the design, implementation, and continuous improvement of equipment validation and asset lifecycle programs.
Manage qualification and validation activities for facilities, equipment, instruments, systems, and software.
Protocol and Report Development
Author and approve validation master plans, protocols (IQ/OQ/PQ), and summary reports.
Ensure documentation meets regulatory and internal quality standards.
Execution and Analysis
Oversee and execute validation protocols, ensuring accurate data collection and analysis.
Interpret results to confirm equipment performance, reliability, and compliance.
Regulatory Compliance
Ensure all validation activities comply with FDA, EU, ICH, ISO and relevant standards.
Risk Assessment and Mitigation
Conduct and lead risk assessments (e.g., FMEA) to identify potential failure modes and implement mitigation strategies.
Cross-Functional Collaboration
Partner with Manufacturing, Facilities, Quality Assurance, IT, Program Management, and external clients to support validation projects and resolve technical issues.
Maintenance of Validated State
Manage requalification and revalidation activities following equipment changes, upgrades, or periodic reviews.
Maintain validated state documentation and change control records.
Salary Range: $90,000 - $105,000 depending on qualifications