CSV Engineer

We are recruiting a CSV Engineer to join a leading pharmaceutical manufacturing organisation based in County Waterford. This is an exciting opportunity for a dedicated professional to support the validation lifecycle of computerized systems and equipment, ensuring ongoing compliance with regulatory standards and contributing to continuous improvement initiatives across various departments.

As a key member of the team, the CSV Engineer will play a vital role in ensuring the validation and lifecycle management of critical systems, working collaboratively with cross-functional teams to maintain compliance and support audit readiness.

This is an initial 12 month contract, with likely extension.

 

KEY DUTIES AND RESPONSIBILITIES

Your duties as the CSV Engineer will be varied however the key duties and responsibilities are as follows:

• As the CSV Engineer, you will support the validation of new computerized equipment, automation, and control systems to ensure compliance with regulatory standards.
• As the CSV Engineer, you will generate, review, and approve validation documentation, including protocols and reports, supporting the validation lifecycle.
• As the CSV Engineer, you will execute and support validation activities including DQ, IQ, OQ, and PQ, ensuring all activities are properly documented and compliant.
• As the CSV Engineer, you will participate in change control processes, providing guidance on Computer System Validation (CSV) requirements and reviewing impact assessments.
• As the CSV Engineer, you will design, implement, and execute validation studies for manufacturing, utility, and control systems, ensuring alignment with industry guidance such as GAMP and ISPE.
• As the CSV Engineer, you will maintain the validated state of computerized systems through effective lifecycle management and revalidation planning.
• As the CSV Engineer, you will support development, review, and approval of validation and revalidation plans, ensuring all activities follow best practices.
• As the CSV Engineer, you will provide technical support regarding current FDA, EU GMP, and industry validation guidance.
• As the CSV Engineer, you will support inspections and audits as required to demonstrate the validity of systems and documentation.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the CSV Engineer we are looking to identify the following on your profile and past history:

• A Degree or higher level in Science (Chemistry, Microbiology, Pharmacy, or related discipline) or Engineering (Chemical, Mechanical, Electrical, or related discipline).
• Proven experience within a life sciences, or pharmaceutical manufacturing environment, including 2 to 3 years in a validation or CSV-specific role.
• Demonstrated experience managing or supporting technical projects in regulated environments, with a strong understanding of CSV principles and lifecycle management.
• Knowledge of GAMP, ISPE guidance, cGMP, and pharmaceutical compliance regulations.
• Effective troubleshooting skills and the ability to work independently and collaboratively in cross-functional teams.

Key Words: pharmaceutical / validation / CSV / compliance / regulated environment / GAMP / cGMP / audit / life sciences / manufacturing / continuous improvement / CSV / Computer Systems Validation / IT Validation / CS Validation / Pharma / CFR 21 Part 11 / 

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.