CQV Engineer

You should have a minimum of 3-4 years of experience in pharmaceutical Commissioning, Qualification, and Validation (CQV). Your responsibilities will include: - Authoring commissioning protocols for equipment and utilities like Reactors, centrifuges, dryers, HPLC, etc. - Coordinating with engineering and Original Equipment Manufacturers (OEMs) for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). - Developing documents such as Design Qualification (DQ), System Impact Assessment, and Risk Assessment in collaboration with OEMs. You will also be required to: - Create, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for process equipment. - Ensure that qualifications are conducted in compliance with regulatory standards such as FDA and WHO. Additionally, you should possess: - Proficiency in good documentation practices and Quality Management System (QMS) processes throughout the CQV lifecycle. - Ability to collaborate with various teams including engineering, manufacturing, Quality Assurance/Quality Control (QA/QC), and Information Technology (IT) to facilitate CQV activities and ensure project success. - Provide technical insights during project planning and scheduling of CQV tasks. - Monitor and communicate the progress of CQV milestones effectively. - Strong project management skills and exceptional communication and writing abilities.,