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Robert Ciociola posted a job:

"Hiring a Packaging Validation Specialist III 019 in Lancaster, PA Packaging Validation Specialist III-Lancaster, PA 019 Contract position-24 months Send resumes to: bciociola@covexllc.com The Packaging Validation Specialist III will be responsible for supporting packaging and CSV validation remediation activities. The focus of this role includes a gap assessment and remediation of existing equipment qualification, CSV and process validations. The Packaging Validation Specialist III is recognized as subject matter expert with respect to solid and liquid dosage packaging validation. Duties will include gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and metrics. In addition, the Packaging Validation Specialist III will be responsible for authoring through execution of packaging validation remediation activites including: 1. Template and work instruction creation for Packaging Process Performance Qualifications 2. Authoring Packaging Process Performance Qualifications 3. Authoring Master Validation Plans for Packaing Lines 4. Data gathering for Master Validation Plan 5. Assessment of current documents including Equipment Qualifications, CSV and Validations against new quality standards. 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 will have the ability to influence and constructively challenge cross-functional technical project teams while partnering with business leaders to achieve project goals is required. 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. Experience writing and reviewing Master Validation Plans, Equipment IQ's, OQ's, PQ's, CSV and Process Validations a must. Contract Length: 24 months Travel: There is no travel anticipated for this role. http://bull.hn/l/UCIS/3"

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