This position will have interactions with Manufacturing, Quality, Engineering and Validation Personnel at both entry and senior level positions. The candidate would need good people skills and get along well with others in a team environment.
Associate Validation Engineer- policies all types of equipment
The Associate Validation Engineer will be responsible for writing and executing validation protocols for equipment and process qualifications. The engineer will complete validation activities in compliance with Quality System requirements and recognized international standards. An emphasis will be placed on risk management and root cause analysis.- reviewing policies and procedures
Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and
Ensure all aspects of validation adhere to required policies and procedures, including safety and training.
Writing and execution/coordination of validation protocol testing.
Compile and report on relevant validation data and generate summary reports to document the results of the
Aides in troubleshooting/impact assessment for atypical conditions during validation runs/validations.
Assist in the development of any existing validation program to ensure continued compliance to the
Must have 3-5 years’ experience with Sterilization Equipment Processing. A combination of Cycle Development; Process Engineering and Validation Engineering
Education And Experience
BS degree in a technical discipline.
Associate Validation Engineer
Possess strong project management, organizational, analytical, computer, writing and communication skills. Knowledge of aseptic processing and terminal sterilization is highly desired. Knowledge of cGMP regulations and latest validation guidelines essential. Must be able to handle multiple priorities in a fast-paced environment. Able to work extended/odd hours around manufacturing schedule as required.
Candidate must be able to Lift and carry light loads as necessary in conducting testing, sitting, standing, walking, weekend or long hours based on testing schedule, wear proper gowning and PPE in manufacturing areas as required to meeting GMP and OSHA requirements.