Job Description

Job Title: CQV Engineer – Sterile Drug Product Facility

Location: Dublin (fully on-site role)
Contract: 5-6 Months

Rate: €75.00 per hour

Job Function

Working in association with the Area CQV Lead, prepare and execute site commissioning and validation testing for equipment and utilities at a sterile drug product manufacturing facility, in alignment with site and global procedures.

Responsibilities

• Develop and execute CQV testing documentation for benchtop equipment and manual inspection booths within the sterile drug product facility.
• Meet key project deliverables for safety, CQV schedule, and quality of project-related documentation and electronic records for assigned equipment and utilities.
• Ensure GMP equipment is tested in compliance with good manufacturing practices, company policies, and EU & FDA regulations.
• Ensure all equipment is tested in compliance with relevant project standards from a commissioning perspective.
• Manage deviations associated with assigned equipment and utilities.
• Identify and categorise CQV risks according to their impact on commissioning and qualification; generate action plans to mitigate qualification risks.
• Execute FAT testing and leverage results into the overall qualification process for assigned equipment, facilities, and utilities.
• Complete all assigned training on time to meet site metrics.

Required Qualifications and Experience

• Minimum of a BS (Degree) in a scientific, technical, or engineering discipline.
• Minimum of 5 years' experience within the pharmaceutical industry, ideally with familiarity in sterile drug product filling line experience.
• Demonstrable capacity to effectively execute the CQV testing approach for assigned equipment, from initiation to completion.
• CQV project lifecycle experience, from design through to C&Q and handover.
• Demonstrable experience working as part of a diverse team of CQV professionals and contractors, delivering tasks safely, on time, within budget, and with a strong quality focus.
• Experience in CQV of drug substance/drug product sterile manufacturing equipment with integrated automation.
• Solid background in document preparation, execution, and task planning on CQV projects, with a demonstrated record of on-time delivery.
• Excellent communication skills and the ability to influence others.
• Demonstrable experience working in teams within a matrix environment to deliver CQV elements.
• Previous experience with an electronic validation platform (e.g. ValGenesis, Kneat) is desirable.

The Next Step for You

Should this position be of interest to you, please forward your CV to Andile Sibanda at Next Generation Recruitment.
Next Generation Recruitment are specialists in Supply Chain, Procurement, Engineering, Quality, Scientific, Technical and Operations recruitment across permanent, contract and temporary positions.

Applications are strictly confidential.