Are you a highly motivated and experienced Commissioning and Qualification (C&Q) Engineer with expertise in clean utilities, facilities, and process equipment? We are seeking a dedicated professional to join our team and ensure the safe, timely, and compliant execution of C&Q activities for a critical capital project.
Role Overview
As a C&Q Engineer for our capital project, you will be instrumental in the successful commissioning and qualification of clean utility systems, facility infrastructure, and process equipment. Your primary goal will be to ensure all C&Q activities are completed safely, on schedule, and in full compliance with GMP and stringent Quality Requirements.
Key Responsibilities
- Lead the Commissioning & Qualification of Clean Utility Systems, facility infrastructure, and process equipment.
- Generate all necessary C&Q test documents, including C&Q Plans, Set to Works, FAT, SAT, IV, FT, and C&Q Summary Reports.
- Provide essential technical assistance during investigations and system design phases.
- Coordinate and supervise all C&Q activities for your assigned systems.
- Actively manage and maintain the C&Q schedule, ensuring project timelines are met.
- Lead daily C&Q coordination meetings to ensure alignment and progress.
- Responsible for tracking and reporting C&Q status, as well as identifying and addressing risks and issues.
- Ensure the safe and coordinated startup of equipment and utilities.
- Assist in the development of User Requirement Specifications (URS) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Education / Experience
- 3+ years of experience in Engineering or Commissioning and Qualification Management.
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects is highly preferred.
- Strong understanding of safety, GMP, and environmental regulatory requirements.
- Demonstrated strong Communication and Leadership skills.
- Proven ability to collaborate effectively with senior stakeholders to achieve optimal outcomes.
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
- Familiarity with paperless validation systems is an advantage.
