The Role
PE Global are recruiting for an
Inspection
C&Q Engineer
for our biopharmaceutical client based in Dublin 15. This is an initial 12 -month contract role. Fully onsite role**
Job Responsibilities
* Development and execution of CQV testing documentation for Inspection Systems including Syringe and Vial Automated Visual Inspection Equipment and Manual Inspection Booths for the Sterile Drug product facility.
* Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned.
* Responsible for ensuring GMP equipment are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
* Responsible for ensuring that all Inspection equipment, is tested in compliance with project related standards from a commissioning perspective.
* Deviation management associated with the assigned equipment and utilities.
* Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.
* Execution of FAT testing and leveraging results into overall qualification process for assigned equipment, facilities and utilities.
* Ensuring all assigned training is executed on time to meet site metrics.
Educations & Experience
* Required Qualification(s) and Desired Experience The ideal candidate should hold 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 industrial ideally with familiarity with Sterile Drug Product filling line experience.
* Demonstratable capacity to effectively execute the CQV testing approach for assigned from initiation to completion.
* 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 CQV of Drug Substance/Drug product sterile manufacturing equipment with integrated automation.
* 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.
* Excellent communication skills and the ability to influence others.
* Demonstratable experience working in teams in a matrix environment to deliver CQV elements.
* Previous experience with electronic validation platform (e.g. ValGenesis, Kneat)..
Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up-to-date CV to
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****