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CSV Engineer - Blarney

Reporting to the Quality Manager – Validation / Principal Validation Engineer, the Computer System Validation (CSV) Engineer is responsible for the design and execution of validation projects and strategies to support the site-based implementation of the manufacturing execution systems (MES) within the production environment.

The CSV Engineer works as part of a cross-functional teams to lead and support validation activities of the MES solutions (Siemens OpCenter, AspenTech) that delivery efficient, accurate and both regulatory compliant & satisfy internal requirements qualifications.

Duties & Responsibilities

• Authoring, reviewing and executing Computer System Validation (CSV) plans, protocols and reports in alignment with GAMP 5 and applicable regulations.

• Ensure site consistently interpret and implements corporate policy across all Computer Systems areas.

• Execute and complete validation activities from software install to business release for site systems including MES solutions (Siemens OpCenter, AspenTech) in accordance with Validation Master Plans, company policies and project schedules.

• Participate in cross-functional teams to establish validation strategies and objectives to support new systems and system upgrades.

• Maintain ongoing understanding and knowledge of requirements for validation in compliance with applicable regulations and guidance documents, provide updates to department management and cross-functional teams.

• Participate in the review of validation practices and trends, identify opportunities for continuous improvement and complete improvement projects.

• Ensuring change control processes are appropriately followed for validated systems. Lead and co-ordinate Risk Mitigation initiatives such as FMEA and Risk Assessments for new systems and upgrades. Completes associated new systems and system upgrades Change Control activities in accordance with Quality Standards and Practices.

• Providing support for CSV activities during internal audits, customer audits and regulatory inspections. Maintaining and updating validation documentation to ensure audit readiness.

• Monitor the progress of validation projects to ensure adherence to schedule and provide regular stakeholder updates.

• Ensure thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent re-occurrence. Reports and escalates critical quality issues to the appropriate level of quality management for approval of final resolution.

• Adhere to all company EHS guidelines and Quality procedures.

Candidate requirements

• B.Sc. in an appropriate Computer Science/Engineering or related discipline
• Minimum 5-8 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces within the pharma/medical device or similar industry
• Proven experience supporting validation of systems such as MES solutions (Siemens OpCenter, AspenTech)
• Working knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity principles
• Proficiency in programming languages and MES platforms (e.g., AspenTech, Siemens, Rockwell)
• Proven technical experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
• Strong oral, presentation and written communication skills are required, with proven ability to communicate and build relationships cross-functionally
• Demonstrated success working in a team environment
• Effective time-management skills to meet project schedules
• Self-motivated, detail-oriented and excellent organizational and time management skills

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!