Senior Automation CQV Engineer - Athlone - Contract
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What you'll do
- Lead the C&Q lifecycle from FAT/SAT through to IQ/OQ execution and regulatory handover.
- Take ownership of the automation qualification and validation deliverables.
- Act as the key technical bridge between external automation vendors, project engineering, and internal Validation/Quality Assurance teams.
- Ensure site systems, from process automation to critical utilities, are fully qualified, compliant, and ready for commercial production.
- Manage automation vendor deliverables, review/approve vendor design documentation (FS, DDS), resolve deviation logs, and drive cross-functional alignment between engineering and quality.
What they're looking for
- CQV Expertise: Deep experience leading C&Q deliverables (GAMP 5, VMP, FAT, SAT, IQ, OQ execution, and validation reporting) within a regulated Biopharma/GMP environment.
- Siemens Proficiency: Strong technical fluency with Siemens PLC platforms (S7, TIA Portal) and SCADA/HMI systems.
- Compliance Rigor: Solid understanding of global regulatory standards, including HPRA/FDA guidelines, Annex 11, and 21 CFR Part 11 compliance for computerized systems.
- Vendor & Stakeholder Management: Proven ability to manage automation vendor deliverables, review/approve vendor design documentation (FS, DDS), resolve deviation logs, and drive cross-functional alignment between engineering and quality.
- On-Site Leadership: A proactive, on-site presence flexible enough to support key commissioning and qualification project milestones.
Nice to have
- Experience with BMS/EMS, Formulation/Compounding, or WFI/Purified Water utilities is highly desirable.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Join a Global Leader at a World-Class Irish Facility
Are you a Siemens PLC/SCADA expert with a proven track record in full-lifecycle Commissioning, Qualification, and Validation (CQV)? Following a major investment phase, a leading global biopharmaceutical company based in Athlone is driving key capital expansion projects.
We are seeking a high-caliber Senior Automation CQV Engineer for an initial 12-month contract to lead the C&Q lifecycle from FAT/SAT through to IQ/OQ execution and regulatory handover.
The Role
Working within a state-of-the-art biomanufacturing facility, you will take ownership of the automation qualification and validation deliverables. This is a hands-on, site-based role where you will act as the key technical bridge between external automation vendors, project engineering, and internal Validation/Quality Assurance teams. You will ensure site systems, from process automation to critical utilities, are fully qualified, compliant, and ready for commercial production.
What You'll Bring
- CQV Expertise: Deep experience leading C&Q deliverables (GAMP 5, VMP, FAT, SAT, IQ, OQ execution, and validation reporting) within a regulated Biopharma/GMP environment.
- Siemens Proficiency: Strong technical fluency with Siemens PLC platforms (S7, TIA Portal) and SCADA/HMI systems. Experience with BMS/EMS, Formulation/Compounding, or WFI/Purified Water utilities is highly desirable.
- Compliance Rigor: Solid understanding of global regulatory standards, including HPRA/FDA guidelines, Annex 11, and 21 CFR Part 11 compliance for computerized systems.
- Vendor & Stakeholder Management: Proven ability to manage automation vendor deliverables, review/approve vendor design documentation (FS, DDS), resolve deviation logs, and drive cross-functional alignment between engineering and quality.
- On-Site Leadership: A proactive, on-site presence flexible enough to support key commissioning and qualification project milestones.
Why This Opportunity?
- 12-Month Contract: Secure a long-term, visible role supporting critical site expansion with potential for extension
- Industry Prestige: Work alongside top-tier talent in a world-renowned biomanufacturing network.
- Project Ownership: Play a pivotal role in qualifying key process and utility control systems during a key growth phase for the site.
- Strong Culture: Join a facility with a proven track record of strong contractor retention and a collaborative project environment.
Ready to Apply?
If you bring strong Siemens automation qualification expertise and are ready to own the CQV lifecycle on a major project, we want to speak with you.
Apply today with your updated CV for a confidential discussion.
Company
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