What are the responsibilities and job description for the Sr. Commissioning, Qualification & Validation Engineer position at Lupin Pharmaceuticals Inc.?
Responsibilities
Lupin Research, Inc. – 4006 NW 124th Avenue, Coral Springs, FL 33065
Title: Sr. Commissioning, Qualification & Validation Engineer
Duties: Lupin Research, Inc. seeks a Sr. Commissioning, Qualification & Validation Engineer in Coral Springs, Florida to perform validation engineering. Support the commissioning and qualification of pharmaceutical manufacturing equipment, utilities, and facilities. Qualify pharmaceutical processes, equipment, utilities, facilities, and computer systems in relation to inhalation products and medical devices. Implement continuous improvement activities for Commissioning & Qualification (C&Q) procedures. Write, review, and execute C&Q documentation including Commissioning Protocols, IQ, OQ, and PQ for pharmaceutical manufacturing equipment, facilities, and utilities. Validate equipment, facilities, and utilities to ensure compliance with ISO standards and ISPE guidelines. Gather and safely manage all data acquired during the C&Q activities to ensure its integrity and use for GMP decisions. Ensure pharmaceutical manufacturing processes are compliant with FDA regulations including 21 CFR Part 11, 211, and 820. Maintain the qualified state of equipment and utilities and assess the potential impact of changes to qualified systems. Identify and implement validation best practices to continuously improve the site validation program. Assist in the troubleshooting or resolution of deviations or failures noted during the commissioning or qualification of equipment, facilities, or utilities for the assurance of the quality of the product or safety of the patient. Use Microsoft Word, Microsoft Excel, Microsoft Project, TrackWise, SAP, and Minitab to track and coordinate validation projects. Participate in the presentation of validation results to regulatory agencies. Annual salary: $115,000.
Requirements: Master’s degree in Validation Engineering, Mechanical Engineering, or a related field plus two years of validation engineering experience. Must have at least two years of experience in each of the following: 1. Supporting the commissioning and qualification of pharmaceutical manufacturing equipment, utilities, and facilities; 2. Writing, reviewing, and executing C&Q documentation including Commissioning Protocols, IQ, OQ, and PQ for pharmaceutical manufacturing equipment, facilities, and utilities; 3. Validating equipment, facilities, and utilities to ensure compliance with ISO standards and ISPE guidelines; 4. Ensuring pharmaceutical manufacturing processes are compliant with FDA regulations including 21 CFR Part 11, 211, and 820; and 5. Using Microsoft Word, Microsoft Excel, Microsoft Project, TrackWise, SAP, and Minitab to track and coordinate validation projects.
To apply, please send resume to USACareers@lupin.com and cite requisition number 00180 or apply at www.lupin.com/US/.
Salary : $115,000
