Validation Engineer II

Position Scope: Performs start-up, commissioning, qualification, validation and revalidation for facility, equipment, critical utility, automationcomputer system, cleaning, sterilization, medical device and drug product manufacturing processes. Strategic Focus Areas:Develops into a subject matter expert in cleaning and sterilization validation. Specific Tactical Responsibilities:Authors, executes, and summarizes qualification and validation protocols.Conducts Risk Impact Assessments and establishes system boundaries.Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs. Provides technical input in determining strategy for validation activities.Represents validation during site GMP activities and participates on cross-functional teams. Coordinates the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or itiates, or provides validation input on quality systems such as CAPAs and change controls.Responsible for other duties and projects as assigned Job Complexity:The job requires the ability to act on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. The position exercises broad judgment within generally defined procedures and practices to determine appropriate action and exercises Supervisory Responsibilities:None Required Qualifications:BS degree in engineering or scientific discipline. 3-5 years of validation experience in biopharmaceutical, medical device or FDA regulated environments. Desired Experience, Knowledge, and Skills:Knowledge of the fundamentals of Steam Sterilization and Cleaning Validation.Knowledge of quality risk management and statistical tools within the context of validation.

Created: 2025-02-21