Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: March 18, 2019
Responsible for the commissioning, qualification, and validation activities across areas of Clinical Supply Operations(Parenteral, Oral Solid Dosage, Packaging and Logistics) and Research and Development External Operations Kilo Lab facilities by utilizing experience in quality, safety, and computerized system regulations applied to Clinical Supply Operations and Bulk Pharmaceuticals. The individual must possess strong commissioning, qualification, and validation fundamentals; and a strong understanding of equipment, facilities, and systems within pharmaceutical and bio-pharmaceutical areas.Duties include planning and executing temperature mappings, sterilization, decontamination, and SIP/CIP studies; controls and instrumentation protocols; project management. Knowledge of cGMPs, EU guidelines, USP, ISO, GAMP, Electronic Records, and Data Integrity industry practices; and proficiency in managing external resources to lead a multi-disciplinary team on the execution of commissioning, qualification and validation activities. Collaborate with various groups within product development & technical operations, to complete shared objectives. Act as a lead role in discussions with quality and regulatory compliance and be comfortable debating differences of philosophy. Generate, review, and execute commissioning, qualification, and validation documents. Provide validation support of equipment re-qualifications and periodic review activities. Maintain GMP facilities in a qualified state at all times. Maintain validation life cycle and validation master plans. Generate risk-based impact assessments, validation project plans, and schedules. Prepare and respond to audits, including audit findings. Required: Bachelor's degree in Chemical Engineering, Mechanical Engineering, Chemistry or a related field plus 5 years of experience reflecting demonstrable ability in the skill set described above.Other Qualifications:In lieu of Bachelor's degree plus 5 years of relevant experience the employer will accept a Master's degree in Chemical Engineering, Mechanical Engineering, Chemistry or a related field plus 3 years of experience reflecting demonstrable ability in the skill set described above.
Keywords: Bristol-Myers Squibb Company, New Brunswick , Validation Engineer, Engineering , New Brunswick, New Jersey
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