Lead, Computer System Validation

Job Title

Lead, Computer System Validation

Requisition

JR000015749 Lead, Computer System Validation (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

Job Scope
Reporting to the Quality Validation Manager within the Quality Systems function in addition to the Heads of Quality for each Internal Manufacturing Site within the Keenova Network. The Computer Systems Validation (CSV) Lead – Global Internal Manufacturing is responsible for leading the implementation, governance, and lifecycle management of GxP computerised systems and automated systems across internal manufacturing sites within the Keenova Network.

The Computer Systems Validation (CSV) Lead – Global Internal Manufacturing must ensure that all Computerised activities and automated systems are aligned with current Engineering and Quality standards. This will include the implementation of new systems and the reassessment of existing systems within the network.

The role ensures that CSV and Computer Software Assurance (CSA) activities are planned, executed, and sustained in alignment with applicable regulatory expectations and company procedures, supporting inspection readiness, data integrity, and reliable operations.

Job Description

Roles and Responsibilities

CSV Governance & Strategy (Network)

Act as CSV subject matter expert (SME) for internal manufacturing sites, providing guidance on requirements, deliverables, and evidence expectations.

Establish and maintain a risk-based CSV/CSA approach across the network (e.g., aligned with GAMP 5 and company CSV procedure).

Define and govern network CSV standards, templates, and best practices; drive harmonisation while allowing site-specific implementation where justified.

Partner with Quality Systems to ensure CSV processes integrate with change control, deviation/CAPA, supplier management, and training.

System Lifecycle Management (Validation & Sustaining)

Own or govern the network inventory of GxP computerised systems (including automation systems) and ensure systems are appropriately classified and assessed.

Lead validation planning for new implementations and major changes (e.g., validation plans, risk assessments, requirements, test strategy, traceability, reports).

Ensure validated state is maintained across the lifecycle via periodic reviews, security/access reviews, audit trail review expectations (as applicable), backup/restore verification, and archival controls.

Oversee automation-related and computerised system change controls, ensuring impact assessments, testing, and documentation are complete prior to release.

Ensure data integrity requirements are defined and met (e.g., ALCOA+ principles; electronic records/e-signatures compliance where applicable).

Cross-Functional Partnership & Operational Support

Provide CSV leadership and support to Quality, Engineering, Manufacturing Operations, Technical Operations, and IT/OT teams at internal sites.

Support capital projects through all phases (concept, design, procurement, build, commissioning/qualification, handover), ensuring CSV deliverables are integrated into project plans.

Guide system owners and SMEs on intended use, validation approach, and sustaining activities (including SOP/work instruction needs).

Drive timely closure of CSV-related deviations, discrepancies, and CAPAs using structured problem-solving and risk-based decision making.

Supplier / Vendor Oversight

Assess and manage CSV/CSA deliverables from vendors and service providers (e.g., leveraging vendor testing/documentation where appropriate).

Partner with Supplier Management to ensure vendor qualification, quality agreements, and service controls support maintaining validated state.

Ensure outsourced validation activities are appropriately scoped, executed, and documented, with clear roles and responsibilities.

Audit / Inspection Readiness

Maintain inspection-ready CSV documentation and evidence for network sites; ensure controlled storage and retrieval.

Support internal and external audits/inspections, including preparation of responses and participation as CSV SME.

Track and report CSV compliance status and key risks to Quality leadership, including network-level trends and recurring issues.

People, Training & Continuous Improvement

Coach site teams on CSV/CSA expectations and sustaining practices; define and deliver role-based training where needed.

Identify and lead continuous improvement initiatives that improve compliance, efficiency, and quality of CSV deliverables.

Contribute to the development and periodic review of CSV procedures, work instructions, and templates.

Experience, Qualifications and Education Requirements

• Master’s degree in engineering, Computer Science, Life Sciences, or equivalent.

Experience

• Significant experience in CSV for GxP-regulated systems in a pharmaceutical/biotech manufacturing environment (typical 5–10+ years, depending on seniority).
• Demonstrated experience leading validation strategy and execution across multiple systems and stakeholders (multi-site experience preferred).
• Hands-on experience with risk assessments, requirements, test strategy, and lifecycle deliverables; maintaining validated state via periodic review and change control.
• Experience supporting regulatory inspections and internal audits as CSV/automation SME.

Competencies / Preferred Skills

Skills / Knowledge

• Strong working knowledge of applicable regulations and guidance for GxP computerised systems (e.g., EU Annex 11, 21 CFR Part 11, GAMP 5) and contemporary CSA principles.
• Understanding of IT/OT in manufacturing environments (e.g., SCADA/PLC/PCS/BMS, MES, LIMS, historian/data systems) and data integrity controls (audit trails, access controls, backup/restore, archival).
• Excellent technical writing and documentation discipline; able to create clear, inspection-ready evidence.
• Strong stakeholder management and communication skills; able to influence across Quality, Engineering, Operations, and IT.
• Proven ability to prioritise workload, manage timelines, and drive closure of actions to committed dates.

Core Competencies

• Quality mindset and strong focus on patient safety, product quality, and data integrity.
• Risk-based decision making and structured problem solving.
• Leadership without authority; ability to drive alignment across multiple sites.
• Continuous improvement orientation (simplification, standardisation, effective leveraging).
• High attention to detail with pragmatic execution.

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.

 

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

 

We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.