Base pay range
* Hourly Rate: up to €75 per hour (DoE)
* Engagement Type: LTD Company Contractor
* Onsite Requirements: This is a site-based role
Job Overview
The Filling C&Q Engineer will work closely with the SDP Area CQV Lead to prepare and execute commissioning and validation testing for equipment and utilities. The role ensures all CQV activities are performed in alignment with site and global procedures, maintaining compliance with GMP, EU, and FDA regulations.
Responsibilities
* Develop and execute CQV testing documentation for filling line systems, including syringe and vial lines, isolators, lyophilisers, and associated equipment.
* Deliver key project milestones related to safety, CQV schedule, and documentation quality.
* Ensure GMP equipment is tested in compliance with company policies and regulatory standards.
* Oversee commissioning compliance for all assigned equipment.
* Manage deviations and associated documentation for equipment and utilities.
* Identify and categorise CQV risks, implementing mitigation plans as required.
* Execute FAT testing and incorporate results into qualification processes.
* Ensure timely completion of all assigned training in line with site metrics.
Requirements
* Minimum BS Degree in a scientific, technical, or engineering discipline.
* 3–5 years of experience within the pharmaceutical industry, ideally in sterile drug product filling line environments (essential).
* Proven experience executing CQV testing from initiation to completion.
* Full project lifecycle experience from design through to commissioning, qualification, and handover.
* Strong background in CQV of sterile manufacturing equipment with integrated automation.
* Demonstrated ability to lead and execute FAT activities (essential).
* Proficient in document preparation, execution, and task planning on CQV projects.
* Excellent communication and stakeholder influencing skills.
* Experience working effectively within matrix teams.
* Previous use of electronic validation platforms (e.g. ValGenesis, Kneat).
Legal Right to Work
Applicants must have the legal right to work in Ireland. Visa sponsorship is not available for this role.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
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