Senior CQV Engineer

Desired Skills: commissioning,qualification,validation,facilities,utilities

The role:

PE Global is currently recruiting for a CQV Engineer on behalf of a leading pharmaceutical company based in Dublin. This is an initial 17-month contract role.

Responsibilities:

• Development and execution of CQV testing documentation for Utilities 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 and utilities assigned.
• Responsible for ensuring Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all non GMP equipment Utilities are 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.
• Interfacing daily with key site stakeholders, vendors, and involved contractors.
• Conduct field inspections, FAT/SAT support, and walkdowns to verify system installation and operation.

Education and 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 industry with familiarity with utility systems commissioning.
• 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 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, chilled water.
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***