Aseptic Process Validation Engineer II

Description: Job Description" Hands-on and Technical Testing Competency o Ability to perform standardized tests per SOP and test methods. o Understands protocols, data collection, and proper use of lab equipment. o Focused on accuracy, repeatability, and compliance o Perform equipment validation (IQ/OQ, etc.) o Prior experience working with *** is strongly preferred. " Data Analysis & Documentation o Capable of analyzing test results, identifying trends or failures, and summarizing findings clearly. o Writes structured test protocol, reports and maintains documentation aligned with quality and regulatory requirements " Problem Solving & Root Cause Analysis o Can identify potential issues in performance and support investigations (e.g., basic CAPA input, troubleshooting test failures). o Collaborates with engineers to improve designs, performance or test methods based on results. " Supports in the designs and development of a wide variety of packaging and/or device used for the protection, display, handling, and delivery of ophthalmic pharma products. " Performs assigned tasks under general supervision in support of approved projects " Executes engineering studies, conduct testing and data analysis under direction of senior OH team members. Receives technical guidance from senior OH staff on the design of experiments. " Applies general technical skills to complete assigned work and solves routine problems of limited scope. " Thoroughly and clearly documents experiments in laboratory notebook and assists in preparation of technical documents. " Drafts protocol and reports to document related activities " Drafts and routes standard operating procedures as required " Drives effective actions for compliance within the agreed timelines " Ensures continual quality system compliance by adherence to established and evolving QS requirements. " Communicates and collaborates with colleagues and with supervisors. " General use, set-up and upkeep of laboratory, including equipment/instrumentation Key Requirements/ Minimum Qualifications: " Bachelor s Degree or Equivalent + 4 years of directly related experience (or high school +8 yrs; Assoc.+6yrs; M.S.+0 yrs), Mechanical Engineering major is desired " The ability fluently read, write and communicate in English. " Work efficiently and productively with other team members and external partners. " Adheres to ***'s guidelines for appropriate workplace behaviors and attitudes " Prior experience working with *** is strongly Custom Fields:Name: Badge ID RequiredValue: YesName: Work Desk Phone Number RequiredValue: YesName: Invoice TypeValue: USA-ARL-Staffing-USDName: Worker Time TypeValue: Full TimeName: Supervisory OrgValue: ()-60000666Name: WorkspaceValue: NoneName: System Access RequiredValue: YesName: Remote WorkerValue: No