Validation Engineer

Responsibilities:

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