CSV Engineer

Grifols, S.A; Dublin; Hybrid; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Highly competitive salary

Annual bonus%

Shares options scheme

Group pension scheme

Private Medical Insurance

Job summary

Grifols, S.A. is seeking an experienced CSV Validation Engineer to join our Validation team.

You will act as an SME for Computer System Validation and validation activities across major capital projects within a highly regulated pharmaceutical environment. This role involves validating software, automated equipment, manufacturing systems, and cloud-based platforms to ensure GMP compliance, data integrity, and regulatory standards.

Qualifications

• Degree in Science, Engineering, or related discipline, with 3+ years' experience in CSV/CSA, Validation, or Quality within biopharmaceuticals.
• Strong experience in Computer System Validation (CSV), Computer Software Assurance (CSA), and qualification of GxP systems and equipment.
• Hands-on experience validating MES, EBR, LIMS, SaaS/cloud-based platforms, and automated systems such as SCADA, BMS, PCS, and DCS.
• Proven experience executing the full equipment and system lifecycle, including FAT, SAT, DQ, IQ, OQ, PQ, QRM, and commissioning/qualification activities.
• Solid knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, data integrity requirements, and ISPE GAMP 5 guidelines.

Responsibilities

• Write, review and execute Validation Protocols and Reports for Equipment, software/automation, and enterprise software systems, ensuring compliance with global and local quality standards.
• Review change controls and assess impact of changes that affect validated systems and define validation requirements.
• Represent validation at internal and external audits by regulatory agencies, including HPRA and FDA.
• Generate and review CSV project documentation (User Requirements Specifications, validation protocols, reports) and SOPs.
• Support validation activities including hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT) to meet GMP requirements and industry standards.
• Maintain the Site Validation Master Plan (VMP) and Project VMPs, defining validation approaches and requalification requirements, and coordinate Re-Validation as needed.
• Complete risk assessments and close corrective and preventive actions.
• Develop alternative solutions to problems and lead qualification/validation efforts across cross-functional teams.

Skills

CSV/CSA experience

Project management

Analytical skills

Communication

Stakeholder management

Education

Degree in Science/Engineering

Tools

MES

EBR

LIMS

SaaS/Cloud platforms

SCADA

BMS

PCS

DCS

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

Position Summary

We are looking for an experienced CSV Validation Engineer to join our Validation team. In this role, you will act as a subject matter expert (SME) for Computer System Validation (CSV) and validation activities across major capital projects.

You will play a key role in validating new software, automated equipment, manufacturing systems, and cloud-based platforms to ensure compliance with GMP, regulatory requirements, and data integrity standards.

This is an excellent opportunity for someone who enjoys working across Quality, Operations, IT, Engineering, and Maintenance teams while contributing to innovative projects in a highly regulated pharmaceutical environment.

• 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.
• Generation and review of CSV project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
• Supporting validation activities including review of documentation 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 VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
• Completion of risk assessments, closure of corrective and preventive actions.
• Develops alternative solutions to problems, handles Highly complexity problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, IT and Maintenance) to lead qualification and validation efforts in support of site projects.
  

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.
• Generation and review of CSV project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
• Supporting validation activities including review of documentation 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 VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
• Completion of risk assessments, closure of corrective and preventive actions.
• Develops alternative solutions to problems, handles Highly complexity problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, IT and Maintenance) to lead qualification and validation efforts in support of site projects.
  

What You’ll Bring

Degree in Science, Engineering, or a related discipline, with3+ years' experience in CSV/CSA, Validation, or Quality within the biopharmaceutical industry.

Strong experience inComputer System Validation (CSV), Computer Software Assurance (CSA), and qualification of GxP systems and equipment.

Hands-on experience validatingMES, EBR, LIMS, SaaS/cloud-based platforms, and automated systems such as SCADA, BMS, PCS, and DCS.

Proven experience executing the full equipment and system lifecycle, including FAT, SAT, DQ, IQ, OQ, PQ, QRM, and commissioning/qualification activities.

Solid knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, data integrity requirements, and ISPE GAMP 5 guidelines.

Experience performing data integrity assessments, data mapping, and data governance activities in line with ALCOA principles.

Strong technical documentation skills, including the preparation and review of SOPs, validation plans, protocols, and reports.

Experience supporting and representing validation functions during internal, corporate, FDA, and HPRA audits.

Strong project management, analytical, problem-solving, communication, and stakeholder management skills, with the ability to work effectively across cross-functional teams.

Experience in an aseptic biopharmaceutical manufacturing environment and familiarity with biopharmaceutical IT infrastructure is highly desirable.

Our Benefits Include:

• Highly competitive salary
• Annual performance based bonus %
• Shares options scheme
• Group pension scheme - Contribution rates are (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
• Wellness activities - Social activities eg. Padel, Summer Events