CQV Engineer Clean Utilities

Cpl Healthcare; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

A renowned biopharmaceutical company is seeking a CQV Engineer specialized in clean utilities systems in Dublin. The role involves executing CQV testing documentation, ensuring GMP compliance, and managing risks related to pharmaceutical equipment. Candidates should possess a BS degree and have at least five years of relevant industry experience.

Qualifications

• Minimum of a BS qualification in a scientific, technical or engineering discipline.
• 5 years of experience within the pharmaceutical industry.
• Experience with CQV of Drug Substance/Drug product sterile manufacturing equipment.

Responsibilities

• Development and execution of CQV testing documentation.
• Ensure compliance with GMP and project related standards.
• Manage risk and deviation associated with assigned equipment.

Skills

CQV Testing

GMP Compliance

Risk Management

Team Collaboration

Communication Skills

Education

BS Degree in scientific, technical or engineering discipline

Tools

ValGenesis

Kneat

Job description

Company Profile:

Our client a globally renowned biopharmaceutical company based in Dublin are hiring for a CQV Engineer specialized in clean utilities systems on an initial 12-month contract for an exciting project. This is an on-site role suited to those with a familiarity working sterile drug product filling line project.

Key Responsibilities:

• Development and execution of CQV testing documentation for Clean 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, utilities assigned.
• Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Responsible for ensuring that all 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.

Essential Requirements:

• A minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline
• 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 and Utilities with integrated automation.
• Specifically experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems. And Clean Steam and High Purity Gas Systems
• 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).

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