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
