MV01-022726 Project Change Controls Generation

Job Description Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:Project Change Controls GenerationDescription:Prior to Change Approval:Conduct meetings with Subject Matter Experts (SMEs) for Change assessments and obtain Change Ratings and a list of required Implementation Steps.Prepare an informal Risk Assessment of the Change with the support of SMEs.Present the Change in the required forums for the "go-ahead" (Quality Board, EHS Board, Process Team Meetings, etc.).Generate the Change in Trackwise, including the creation of Implementation Steps.Follow up with approvers when the Change is in the approval process.Make corrections to the Change based on approvers' feedback.After the Change is Approved:Prepare Reports (e.g., Change status reports, Implementation Steps, etc.).Follow up with Executors for Step completion.Generate Amendments and Extensions as necessary.Attending Project meetings as required.Hold meetings with SMEs during the execution of the Change to clarify Step details, such as the evidence required for Step closure, etc.Conduct meetings with the Change evaluator when Steps have been closed to ensure that all activities have been executed successfully.Provide support for closing Steps that are pending during the final stage. This may sometimes include Step execution.Assignment and execution of Steps (depends on the expertise required for execution and access needed to complete the Steps).Procure documentation for Step closure and close the assigned Steps.Qualifications:Bachelor's Degree in Engineering or Science.Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.Experience in direct process / manufacturing areas.Must be fully bilingual (English / Spanish) with excellent oral skills.Must be proficient using MS Windows and Microsoft Office applications.Technical Writing skills and investigations processes.Available to work extended hours, possibility of weekends and holidays.