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Title: Process Validation Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Permanent
- Pay rate: Open – Market Rate
- Job Location: Leominster, MA
- Job#: bh12625
Process Validation Engineer
The Process/Validation Engineer will oversee, evaluate, and calibrate equipment, systems, and procedures used in the development and production of products and will ensure safety, quality, and purity requirements are met.
• Consults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards
• Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing
• Identifies root causes of production problems
• Identifies nonconformities of product or process standard and offers recommendations for resolving deviations
• Develops and maintains databases for tracking test results, validation activities, or validated systems
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices
• Modifies testing methods or revisits test objectives and standards to resolve testing problems
• Calibrates equipment to ensure accurate measurements
• Performs other related duties as assigned
• Must know all aspect of the injection molding process
• Must fill out process data logs and monitor the setting to make sure they stay in the validated state
• Thorough understanding of related equipment and the ability to perform equipment modifications
• Thorough understanding of industry standards and regulatory guidelines
• Thorough understanding of applicable mathematics and scientific practices
• Must be able to create floor layouts to make jobs streamline and be more efficient for our operators.
• Bachelor’s degree in related field required.
• At least one year of related experience preferred.
• Excellent verbal and written communication skills
• Excellent interpersonal skills
• Proficient with Microsoft Office Suite or related software
• Scientific mold experience, a must
• Priamus or RJG experience a plus
• Can perform DOE as part of process development
• Lean manufacturing, a plus
• Must be able to excuse IQ-OQ-PQ Protocols
• Knowledge of Minitab a plus
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