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Validation Manager
4 weeks ago
Responsibilities
- 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.
Job Requirements
- Bachelor’s degree in mechanical or Electrical Engineering preferred. Life sciences or related fields are also welcomed to apply.
- 2 – 5 years’ experience as validation engineer or similar role, preferably in biopharmaceutical industry
- Thorough understanding of industry standards in biopharma / biomanufacturing and regulatory guidelines
- Attention to details
- Excellent mathematical skills and analytical skills
- Excellent organizational and interpersonal skills
- Highly motivated, passion for science, committed to laboratory work and able to work flexible hours
- Ability to multitask, work independently and also as part of a team. Excellent communication (verbal and written) and presentation skills
Tell employers what skills you have
Ability to Multitask
Performance Testing
Credit Risk Management
Microsoft Excel
Engineering Management
Data Management
GMP
Attention to Details
Econometrics
Stress Testing
Life Sciences
Laboratory
Manufacturing
Electrical Engineering
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