Job Description: The Senior Validation Engineer will be required to become a subject matter expert (SME) in Validation, provide technical expertise and guidance to management and cross functions. The Senior Validation Engineer will be required to defend their area of expertise in regulatory and customer audits. The Senior Validation Engineer will manage the validation of new products/process, as well as changes to existing products/processes, and will work closely with cross functions (laboratory, production, engineering, automation, quality, and BT) to ensure that requirements are met. Job Responsibilities: Perform job responsibilities in compliance with cGMP, regulatory requirements, company policies and standards. Coordinate/oversee/manage the development of new processes or troubleshoot existing ones. Manages and leads contract resources on their assigned projects. Presents area of expertise in Regulatory Agency when necessary. Oversees and assist Engineers and/or Technicians with their assigned projects. Author, execute, or review Validation documents such as: Validation Project Plans, Qualification Project Plan Reports, Validation Qualification Reports, Validation Qualification Protocols, Risk Management tools, Cleaning Calculations, Formulation Evaluations, and Deviation Handling. Schedules and executes validations/qualifications per Standard Operating Procedures (SOPs) and regulatory guidelines. Act as area SME and provide technical expertise to define approaches and execution of applicable process/cleaning validation activities in accordance with cGMP and other applicable regulations, procedures and industry guidance. Participates in teams assembled to specify, validate, troubleshoot and maintain processes. Coordinates and communicates all testing with affected functional groups and evaluates test results. Participate and/or own Pfizer Quality Standard (PQS) CAS Report(s) and responses related to their area of expertise. Job Requirements: Must be able and willing to work beyond office hours which may include weekends, holidays and nights Acute mental and visual attention at all times Handle multiple projects while managing frequent interruptions Requires regular onsite attendance and ability to work remotely when necessary Must be capable of supporting up to 10% travel (domestic and international) Must have the ability to work effectively under strict deadlines Requires routine sitting, standing, walking, listening and talking Requires moderate lifting or moving up to 25 pounds (lbs) Qualification & Experience: Ability to work independently with limited managerial oversight Good written and oral communication skills 3-5 years of direct validation experience preferred 7+ year experience in a cGMP environment Bachelor’s degree in Engineering, Science, or related field5+ year experience in a cGMP environment (3+ year with Masters degree) Strong understanding of CGMPs, (Electronic Records and Electronic Signatures), industry good practices for PQ/CQ and Standard Operating Procedures Job Details: Company: Pfizer Vacancy Type: Full Time Job Location: Hutchinson, KS, US Application Deadline: N/A Apply Here vacanciesforyou.net
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