- Posted 29 April 2026
- LocationIreland
- Job type Contract
- DisciplineBiotechnology
- Reference2295
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QA CSV Specialist
Job description
Position: QA Computer Systems Validation (CSV)
Role Type: 12 Month Contract
Location: Dublin 15
We are seeking to recruit a QA Computer Systems Validation (CSV) Specialist. This contract position will be in the Sterile Drug Product QA Technical Operations team.
Reporting to the Snr Manager, Sterile Drug Product, QA Technical Operations for Sterile Drug Product. This role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, and CQV / CSV / Automation through all phases of the project up to and including Equipment PQ. The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite.
Key Responsibilities
• Provide support to start up activities (Design, Build, CSV / CQV), and GMP operational readiness
• Partnership with CSV & CQV teams in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and documentation for manufacturing operations.
• Collaboration with functional areas for qualification to ensure knowledge transfer and robustness of control strategies.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Qualifications & Experience
The successful candidate must possess:
• Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years’ experience in Sterile Drug Product Manufacturing
• Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
• The candidate will have proven success working well in a team environment
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task
On-site Protocol
This role is considered site-by-design role. Site-by-design roles are eligible for a hybrid work model with at least 50% onsite at your assigned facility.
Role Type: 12 Month Contract
Location: Dublin 15
We are seeking to recruit a QA Computer Systems Validation (CSV) Specialist. This contract position will be in the Sterile Drug Product QA Technical Operations team.
Reporting to the Snr Manager, Sterile Drug Product, QA Technical Operations for Sterile Drug Product. This role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. They will support GMP design reviews, and CQV / CSV / Automation through all phases of the project up to and including Equipment PQ. The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite.
Key Responsibilities
• Provide support to start up activities (Design, Build, CSV / CQV), and GMP operational readiness
• Partnership with CSV & CQV teams in delivering the GMP scope of work associated with the startup of sterile drug product operations at Cruiserath, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and documentation for manufacturing operations.
• Collaboration with functional areas for qualification to ensure knowledge transfer and robustness of control strategies.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Qualifications & Experience
The successful candidate must possess:
• Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years’ experience in Sterile Drug Product Manufacturing
• Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.
• The candidate will have proven success working well in a team environment
• Detailed knowledge of Sterile Drug Product would be a distinct advantage.
• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task
On-site Protocol
This role is considered site-by-design role. Site-by-design roles are eligible for a hybrid work model with at least 50% onsite at your assigned facility.