- Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
- Develops validation master plans, validation protocols, process flow diagrams, test cases, or standard operating procedures.
- Identifies deviations from established equipment, product or process standards and provide recommendations for resolving deviations.
- Conducts validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
- Coordinates the implementation or scheduling of validation testing with affected departments and personnel.
- Adheres to all customer/company and GMP procedures, along with safety regulations within the workplace.
Desired Skills & Experience
- Bachelor's degree in a technical field i.e., Biology, Chemistry, Engineering and minimum 2 to 10 years related experience and/or training; or equivalent combination of education and experience.
- Experience Writing and Executing Protocols
- Strong understanding of Equipment and Processes including Tanks, Columns, USP Water Systems, and HVAC Equipment.
- Experience writing User Requirements, Functional Requirements, Design Specifications, FAT’s, SAT’s, IQ’s, OQ’s, PQ’s.
- Experience executing FAT’s, SAT’s, receipt verification, IQ, OQ, PQ.
- Knowledge of cGMP Cleaning Validation requirements and techniques.
- Knowledge of cGMP Equipment, Process and Product Validation requirements and techniques