Manufacturing Validation Analyst - Pharmaceutical - Dublin

Manufacturing Validation Analyst (CSV/CQV) - pharmaceutical, biotechnology -Dublin - £500- £600 OUTSIDE IR35

Must work onsite full time in Dublin

Help deliver compliant, production-ready manufacturing systems across Ireland's pharmaceutical and biotechnology sector.

We are looking for an experienced Manufacturing Validation Analyst to support computerised system validation (CSV), commissioning, qualification and validation (CQV) activities within regulated life sciences manufacturing environments. Working on-site in Ireland, you will collaborate with Manufacturing, Engineering, Automation, Quality, IT and Operations teams to bring equipment and systems from design and installation through qualification, production release and ongoing life cycle management.

What You'll Do

• Plan, develop and execute DQ, IQ, OQ, PQ and requalification activities for manufacturing equipment and utilities.
• Support commissioning, FAT, SAT, design reviews, qualification readiness and equipment release to use.
• Deliver CSV for MES, SCADA, PLC, HMI, electronic batch record, historian, ERP, QMS and other GxP systems.
• Prepare and maintain validation documentation, including URS, risk assessments, validation plans, traceability matrices, test protocols, deviations and summary reports.
• Test automation functionality such as control sequences, recipes, alarms, interlocks, interfaces, audit trails and data integrity controls.
• Support change control, periodic review, deviations, CAPA, upgrades and validated-state maintenance.
• Work with site teams to coordinate testing safely and effectively around production schedules and operational constraints.

What You'll Bring

• A degree in Engineering, Life Sciences, Computer Science, Manufacturing, Automation or a related discipline, or equivalent relevant industry experience.
• At least three years' experience in equipment qualification, CSV, CQV or manufacturing automation validation within a GxP-regulated environment.
• Hands-on experience executing validation or qualification protocols in pharmaceutical or biotechnology manufacturing.
• Experience with IQ/OQ/PQ documentation, test protocols, risk assessments, traceability and qualification reporting.
• Working knowledge of EU GMP Annex 11 and Annex 15, GAMP 5 and data integrity principles.
• The ability to interpret technical documentation and translate equipment or system requirements into clear, executable tests.
• Strong technical writing, problem-solving and cross-functional communication skills.
• Availability to work on-site in operational manufacturing facilities in Ireland.

Desirable Experience

Experience with bioreactors, chromatography skids, filtration or filling systems, packaging lines, autoclaves, CIP/SIP, clean utilities or sterile manufacturing would be valuable. Familiarity with platforms such as Rockwell Automation/Allen-Bradley, Siemens or Emerson DeltaV, and tools such as ValGenesis, Veeva, MasterControl, TrackWise or HP ALM, would also be beneficial. Knowledge of EU GMP Annex 1, ASTM E2500, ISPE guidance or Computer Software Assurance principles is an advantage.

Why Apply?

This is an opportunity to make a visible impact on the safety, compliance and performance of critical manufacturing systems while working with multidisciplinary teams in complex, highly regulated environments.

Ready to bring your validation expertise to high-impact life sciences projects? Apply now with your CV and a brief summary of your relevant CSV/CQV experience.

This temporary contract is outside IR35 and will be delivered on a statement-of-work basis. The supplier will determine the method, resources, and approach to deliver the agreed outcomes

Damia Group Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept our Data Protection Policy which can be found on our website.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and ability to perform the duties of the job.

Should the role require the successful candidate to undergo and be eligible for UK Security Vetting. Clearance sponsorship will be provided where required. Due to the nature of the work, candidates should meet the relevant residency requirements. If applicable, Reserved Post nationality restrictions will be confirmed by the client. Damia is committed to inclusive recruitment and welcomes applicants from all backgrounds.

Damia Group is acting as an Employment Business in relation to this vacancy and in accordance to Conduct Regulations 2003.