CQV Equipment Engineer - Sterile Drug Product Facility (Contract)
Are you a highly skilled and experienced CQV (Commissioning, Qualification, and Validation) Equipment Engineer with a strong background in sterile drug product manufacturing? We are seeking a dedicated professional to join our team and play a critical role in ensuring the compliance and operational readiness of our sterile drug product facility's equipment and utilities.
Role Overview
As a CQV Equipment Engineer, you will be responsible for the development and execution of CQV testing documentation for utilities and equipment within our Sterile Drug Product Facility. Your expertise will be vital in ensuring that all systems adhere to Good Manufacturing Practices (GMP), company policies, and relevant EU & FDA regulations, contributing significantly to key project deliverables for safety, schedule, and quality.
Key Responsibilities
- Develop and execute CQV testing documentation for utilities and equipment within the Sterile Drug Product Facility.
- Drive key project deliverables, ensuring adherence to safety, CQV schedule, and quality standards for all project-related documentation and electronic records.
- Ensure all utility systems are tested in compliance with Good Manufacturing Practices (GMP), company policies, and EU & FDA regulations.
- Oversee the testing of non-GMP equipment and utilities in accordance with project-related commissioning standards.
- Manage deviations associated with assigned equipment and utilities, including investigation and resolution.
- Perform risk management, identifying and categorizing CQV risks based on their impact on commissioning and qualification, and generating mitigation action plans.
- Execute Factory Acceptance Testing (FAT) and leverage results effectively into the overall qualification process for assigned equipment, facilities, and utilities.
- Ensure all assigned training is completed on time to meet site metrics.
- Maintain daily interface with key site stakeholders, vendors, and involved contractors.
- Conduct field inspections, provide FAT/SAT support, and perform walkdowns to verify system installation and operation.
Required Competencies
- Demonstrable capacity to effectively execute the CQV testing approach for assigned systems from initiation to completion.
- Proven experience across the entire CQV project lifecycle, from design through to commissioning, qualification, and handover.
- Demonstrable experience performing as part of a diverse team of CQV professionals/contractors, consistently delivering tasks safely, with a focus on quality, 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, and chilled water.
- Solid background in 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 effectively.
- Demonstrable experience working collaboratively in matrix environments to deliver CQV elements.
Required Qualifications & Desired Experience
- Minimum of a Bachelor of Science (BS) qualification (Degree) in a scientific, technical, or engineering discipline.
- Minimum of 5 years of experience within the pharmaceutical industry, with familiarity with utility systems commissioning.
