CSV Engineer

Grifols Shared Services North America, Inc; Dublin; On-site; EUR 85,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Performance bonus

Share options

Pension scheme

Private medical insurance

Career development

Succession planning

Education allowance

Wellness activities

Job summary

Grifols is seeking an experienced CSV Validation Engineer to join our Validation team. You will serve as SME for Computer System Validation across major projects, validating software, equipment and cloud platforms to meet GMP and data integrity standards.

You will collaborate with Quality, Operations, IT and Maintenance, ensuring adherence to global validation standards and regulatory expectations while supporting audits and documentation efforts.

Qualifications

• Experience in CSV/CSA and quality within biopharma.
• Experience validating MES, EBR, LIMS, SaaS/cloud platforms.
• Knowledge of GxP, cGMP, FDA 21 CFR Part 11, EU Annex 1, ISPE GAMP5.
• Experience executing FAT, SAT, IQ, OQ, PQ, QRM, commissioning.
• Data integrity assessments and ALCOA principles.
• Strong technical documentation skills.
• Audits during FDA/HPRA and internal audits.
• Cross-functional collaboration across Quality, Operations, IT.

Responsibilities

• Write, review and execute Validation Protocols and Reports (Equipment, software/automation, and enterprise systems).
• Review change controls and assess impact on validated systems and validation requirements.
• Represent Validation at internal and external audits by regulatory agencies (HPRA, FDA).
• Generate and review CSV project docs (URs, protocols, reports) and SOPs.
• Support validation activities including hands-on execution (FAT, SAT, IQ, OQ, PQ, UAT).
• Maintain Site Validation Master Plan (VMP) and Project VMPs, define validation approach and requalification requirements.
• Complete risk assessments and closure of CAPAs.
• Develop solutions and lead qualification/validation efforts across departments.

Skills

CSV/CSA experience

GxP qualification

Data integrity

Documentation skills

Audits support

Cross-functional work

MES/EBR/LIMS validation

SaaS/cloud platforms

FAT/SAT/IQ/OQ/PQ

Regulatory compliance

Education

Science/Engineering degree

Tools

MES

EBR

LIMS

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.

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 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.

• 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

• Education allowance

• Wellness activities - Social activities eg. Padel, Summer Events

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you

#LI-FD1

Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 (https://www.google.com/maps/place//data=!4m2!3m1!1s0x486773bd46855f9f:0xbe0e9ad7159de122?sa=X&ved=1t:8290&ictx=111)

Learn more about Grifols

Req ID: 545831

Type: Regular Full-Time

Job Category: