Process Validation Engineer II - Littleton, United States - Insight Global
Description
Insight Global is looking for a Process Validation Engineer for a Medical Device company located in Littleton, Colorado to sit onsite five days a week.
The Process Validation Engineer will be dedicated to the automation equipment within the clients manufacturing facility, responsible for supporting the validation and quality engineering of various systems in a medical device manufacturing environment, and assure the equipment/system and validation records are compliant with company standards and industry practices.
The position requires independent evaluation, selection and application of standard engineering techniques, procedures, and criteria, using judgment and ingenuity in making minor adaptations and modifications.
Assignments include equipment and process validation, tests method validation, process characterization, research investigations, report preparation and other activities of limited scope.
Additional responsibilities include:
Carry out all aspects of a validation project, which includes: authoring and executing Validation Master Plan (VMP), Validation Plan (VP), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), protocols/report in accordance with established procedures.
Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps and corrective actions.
Provide technical input with respect to Standard Operating Procedures development.Revise or develop SOP's as required to assure that all needs are addressed, and compliance and industry standards are incorporated.
Medical Device experience4+ years of Process Validation experience
2+ years of experience with validating automated equipment
Understanding of and adherence to GMP practices and FDA regulations.
Knowledge and ability to implement FDA or regulatory requirements as necessary