Job Title: C&Q Validation Specialist
We are seeking an experienced C&Q Validation Specialist to join our team in Dublin, Ireland. The successful candidate will work closely with the Area CQV Lead to prepare and execute site commissioning and validation testing for equipment utilities.
This role requires a high level of organizational skills, ability to work under pressure, and excellent communication skills. As part of our team, you will be responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
About the Role:
* Minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline
* Minimum of 5 years of experience within the pharmaceutical industrial 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 diverse team of CQV professionals/contractors to deliver on tasks safely, with quality focus, on time and within budget
* Experience in leading, managing, and execution of 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 platform (e.g., Val Genesis, Kneat)
Key Responsibilities:
* Develop and execute CQV testing documentation for Inspection Systems, Syringe and Vial Automated Visual Inspection Equipment, and Manual Inspection Booths for the Sterile Drug product facility.
* Work closely with the Area CQV Lead to ensure site commissioning and validation testing is completed in accordance with site and global procedures.
* Collaborate with cross-functional teams to identify and mitigate potential risks associated with equipment validation.
Requirements:
* Strong knowledge of GMP regulations and guidelines
* Excellent communication and interpersonal skills
* Ability to work effectively in a fast-paced environment
* Highly organized and detail-oriented individual