CQV Engineer New
Job Summary:
We are seeking a skilled CQV Engineer to join our team on an initial 12-month contract basis. The successful candidate will be responsible for the development and execution of CQV testing documentation for Utilities for the Sterile Drug product facility.
Key Responsibilities:
- Develop and execute CQV testing documentation for Utilities, ensuring compliance with good manufacturing practices, company policies, and EU & FDA regulations.
- Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation/electronic records for equipment and utilities assigned.
- Ensure Utilities are tested in compliance with project-related standards from a commissioning perspective.
- Manage deviations associated with assigned equipment and utilities.
- Identify and categorize CQV risks according to impact on commissioning and qualification, generating action plans to mitigate qualification risks.
- Execute FAT testing and leverage results into the overall qualification process for assigned equipment, facilities, and utilities.
- Ensure all assigned training is executed on time to meet site metrics.
- Interface daily with key site stakeholders, vendors, and involved contractors.
Requirements:
- A minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline, along with a minimum of 5 years of experience within the pharmaceutical industry with familiarity with utility systems commissioning.
- Demonstratable capacity to effectively execute the CQV testing approach for assigned tasks from initiation to completion.
- CQV project lifecycle experience from design through to C&Q and handover.
- Demonstrable experience of performing as part of a diverse team of CQV professionals/contractors to deliver on tasks safely, with quality focus, on time, and within budget.
- Experience in CQV of Drug Substance/Drug product sterile manufacturing equipment and Utilities with integrated automation platforms.
- Specific experience with the CQV preparation and execution for black utility systems, including compressed air plant steam, process waste, chilled water.
- Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.
- Excellent communication skills and the ability to influence others.
- Demonstratable experience working in teams in a matrix environment to deliver CQV elements.
Additional Information:
The ideal candidate will have excellent communication skills, be able to influence others, and possess a solid background of document preparation, execution, and task planning on CQV projects.