Job Opportunity: We are seeking a C&Q Engineer to join our team in Dublin. This is an excellent opportunity for a professional with experience in Commissioning, Qualification, and Validation (C&Q) to work on projects involving Sterile Drug Product filling lines.
**About the Job**: The successful candidate will be responsible for working with the Area CQV Lead to prepare and execute site commissioning and validation testing for equipment utilities. They will also develop and execute CQV testing documentation for Inspection Systems, including Automated Visual Inspection Equipment and Manual Inspection Booths. Additionally, they will be responsible for meeting key project deliverables for safety, CQV schedule, and quality of project-related documentation/electronic records for equipment and utilities assigned. The candidate will ensure that GMP equipment is tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations. Furthermore, they will manage deviations associated with assigned equipment and utilities.
**Required Skills and Qualifications**:
* Minimum of a BS qualification in a scientific, technical, or engineering discipline.
* Minimum of 5 years of experience within the pharmaceutical industry, ideally with familiarity with Sterile Drug Product filling line experience.
* 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 tasks safely, with a quality focus, on time, and within budget.
* Experience in leading, managing, and executing FAT activities.
* Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on-time performance.
* Previous experience with electronic validation platforms (e.g., ValGenesis, Kneat).