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Robert Ciociola posted a job:

"Looking for a Packaging Validation Specialist 406 in Lancaster, PA Packaging Validation Specialist -Lancaster,PA 406 Contract position-20 Months Send resumes to: bciociola@covexllc.com The Packaging Validation Specialist II will be responsible for supporting packaging line validation remediation activities. The focus of this role includes a gap assessment and remediation of existing equipment qualifications and packaging process performance qualification. The Packaging Validation Specialist II is recognized as subject matter expert with respect to solid dosage packaging line qualifications and validation. Duties will include a gap assessment of existing qualification and validation documents utilizing a protocol and checklist. In addition, the Packaging Validation Specialist II will be responsible for authoring through execution of packaging validation remediation activites including, but not limited to: 1. Authoring Remediation Plans 2. Authoring & Executing Packaging Performance Qualifications and Process Performance Qualifications 3. Updating Standard Operating Procedures to address Gaps 4. Authoring Master Validation Plans Education: • A minimum of a Bachelors of Science degree in Engineering or Technical discipline Experience/ Technical Competencies: • A minimum of a Bachelors of Science degree in Engineering or Technical discipline with a minimum of 3 years experience in equipment qualifications and validations for FDA regulated products. Job Knowledge/Skillsets: The candidate must be a driven, goal oriented, technical person with excellent communication, analytical and leadership skills. The candidate must have a proven track record of meeting project objectives by successfully planning, tracking and executing validation projects with respect to scope, quality, time and cost. The candidate must be able to successfully execute several projects concurrently. *Strong technical writing skills *Familiar with Risk Based Approach to Commissioning and Qualification Travel: No travel is anticipated in this role. Contract Length: 20 months http://bull.hn/l/T9RU/"

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