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Position Summary
The CSV Validation Engineer serves as the subject matter expert (SME) within the Validation team, leading validation strategies for major capital projects. This role involves planning and executing validation activities for new software, automated equipment, and enterprise or cloud-based systems (SaaS). The engineer will represent Validation in technical forums, including internal and external audits, and act as a site champion for data integrity. Responsibilities include authoring and reviewing validation plans, protocols, and reports while ensuring compliance with global and local quality standards. Initial focus areas will include automation and CSV, supporting GxP compliance and operational excellence.
What you’ll do
Write, review and execute Validation Protocols and Reports (for Equipment, software/automation, and enterprise software systems) ensuring compliance to all relevant global and local quality and validation procedures/standards.
Review change controls and assess impact of changes that affect validated systems and define validation requirements.
Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
Generate and review CSV project documentation (User Requirement Specifications, validation protocols, reports, etc.) and Standard Operating Procedures.
Support validation activities including review of documentation and hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc.) to ensure equipment/software meets current GMP requirements and industry standards.
Maintain the Site Validation Master Plan (VMP) and associated Project VMPs, defining the validation approach for each piece of equipment, system, process and the re‑qualification requirements including study requirements and frequency. Execute/coordinate Re‑Validation activities as required.
Complete risk assessments and closure of corrective and preventive actions.
Develop alternative solutions to problems, handle highly complex problems independently, demonstrate technical knowledge and ability to adapt to changing circumstances, and work with Operations, Quality, IT and Maintenance to lead qualification and validation efforts in support of site projects.
What you’ll bring
Project Management Experience.
Hands‑on knowledge of execution of Validation.
Experience in validation of MES /EBR/LIMS and other enterprise systems (SaaS/cloud‑based systems).
Experience with automated equipment (SCADA/BMS/DCS).
Solid knowledge of GxP, FDA 21 CFR Part 11, EU Annex 1 and ISPE GAMP 5 guidelines.
Experience in a Quality or Validation Role within the Pharma sector.
At least 2 years of Equipment qualification experience (GAMP, Equipment life cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ); experience with performing data integrity assessments and data mapping.
Excellent Technical Writing and analytical skills.
Familiarity with cGMPs and industry and federal guidelines required.
Experience with Word, Excel and Access computer applications.
Strong interpersonal skills for interactions with other departments.
Degree in Science/Engineering and/or minimum 4 years CSV/CSA Validation experience.
Experience representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits.
Experience within aseptic manufacturing environment.
PCS/DCS and automation experience.
Key Competencies
Project Management skills.
Computer System Validation and knowledge of CSA.
Commissioning and Qualification.
Documentation (Writing SOPs, Protocols, Reports).
Data Integrity, data mapping and data governance (ALOCA principles).
Auditing.
Strong communication/presentation skills during internal/external audits.
Familiarity with IT infrastructure and applications in a pharmaceutical/biopharmaceutical environment.
Ability to collaborate in cross‑functional teams. Problem‑solving and organisation skills.
Our Benefits Include
Highly competitive salary.
Group pension scheme – Contribution rates are 1.5% / 3% / 5% / 7% and company will match.
Private Medical Insurance for the employee.
Ongoing opportunities for career development in a rapidly expanding work environment.
Succession planning and internal promotions.
Education allowance.
Wellness activities – Social activities such as Padel, Summer Events.
Location
Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3
Req ID: 537214
Type: Regular Full-Time
Job Category: Manufacturing
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