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Validation Specialist

Real Staffing

This is a Full-time position in Tannersville, PA posted December 30, 2020.

nn nn nn Title: Validation Specialistnn nn Location: Swiftwater, PAnn nn Duration: 6 Month contractnn nn About the Company: A global biopharmaceutical company focused on healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions and consumer healthcare.nn nn Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.nn nn About the Role: The Validation Specialist will be responsible for generating development / validation protocols and reports, compiling data packs and analyzing data for adherence to established acceptance criteria.nn nn nn nn Your Main Responsibilities: nn Visual Inspection process validation Formulation process validation Filling process validation Executing process validations hands on Understanding of defect criteria, stability and extractables / leachable.

Typical processes being developed / validated include visual inspection, defect set creation and evaluation.

For Visual Inspection, significant experience from production or engineering assignments to have in-depth knowledge of vial and/or syringe filling and inspection equipment sufficient to identify process CPP’s and generate detailed validation protocol requirements and execution nn Required Experience/Skills: nn BS/MS in Engineering, Life Science or Physical Science Visual Inspection in a Pharmaceutical Experience (Pharma Experience only) Experience 5 to 7 years.

Experience in, Process Validation (Visual Inspection), Performance Qualification, E&L, CCIT, shipping validation and/or Filter Validation Strong root cause analysis skills with cGMP experience.

Must be proficient in Geode with a working knowledge of templates, workflows and approval process nnSthree US is acting as an Employment Business in relation to this vacancy.nn
– provided by Dice