Validation Engineer

Grifols; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Performance-based bonus

Share option scheme

Group pension with company match

Private medical insurance

Job summary

Grifols invites talented professionals to join its Dublin area team, driving qualification, validation, and compliance across facilities, utilities, and processing equipment. You will lead validation studies, support regulatory interactions, and contribute to continuous improvement initiatives in a highly technical environment.

The role emphasizes collaboration with Manufacturing, QA, QC, Engineering, Supply Chain, and Global Regulatory, ensuring timely milestones and robust documentation.

Qualifications

• Degree in biochemistry, chemistry, pharmaceutical science, biology, or engineering or equivalent experience.
• 3+ years in pharmaceutical manufacturing with validation of facilities, utilities, and equipment.
• Excellent verbal and written communication, and ability to interface with all levels of the organization.

Responsibilities

• Define, execute, and report qualification, re‑qualification, and validation studies for facilities, utilities, and equipment.
• Provide technical expertise for investigation and resolution of non‑conformances during requalification and revalidation.
• Advise system owners and vendors on suitability and standards for new systems.
• Support regulatory inspections and interactions with agencies (HPRA/FDA).
• Participate in continuous improvement, operational excellence, and lean initiatives.
• Generate project documentation and SOPs; maintain Validation Master Plan (VMP).
• Review change controls and assess impact on validated systems; close CAPAs/DEVs.
• Build relationships with Manufacturing, QA, QC, Engineering, Supply Chain, Regulatory.

Skills

Verbal communication

Written communication

Team collaboration

Project management

Analytical thinking

Education

BSc/MSc/PhD in relevant field

Tools

SAP

Veeva Vault

Excel

Word

PowerPoint

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

The successful candidate will be a key contributor to a dynamic and highly technical team and will be required to build collaborations with Manufacturing, Engineering, Supply Chain, Quality Assurance, Quality Control and Global Regulatory groups. The position is accountable for the timely completion of Utilities, Facilities, and equipment qualification related milestones, PPQ, process monitoring and manufacturing support.

What You’ll Do

• Define, execute, and report qualification, re‑qualification, and validation studies to establish and maintain qualified/validated status of facilities, utilities, and equipment in accordance with internal procedures, regulatory requirements, and industry guidance/standards.
• Provide technical expertise for investigation and compliant resolution of non‑conformances encountered during requalification, revalidation, and periodic review activities.
• Advise system owners and vendors on suitability and required standards/functionality of new systems during the selection process.
• Strong knowledge of cGMP compliance, site and regulatory agency requirements and provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
• Participate in continuous improvement initiatives, action plans to implement operational excellence, lean practices, and set and maintain department goals and metrics.
• Generate and review project documentation (User Requirement Specifications, validation protocols, reports, etc.) and Standard Operating Procedures.
• Create and update Validation Master Plan (VMP), defining the approach and validation requirements for each system, process, and requalification requirements including study requirements and frequency.
• Complete risk assessments and close corrective and preventive actions and deviations.
• Review change controls, 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.
• Build effective working relationships with other functional organizations such as Manufacturing, Quality Assurance, Quality Control, Engineering, Supply Chain, Regulatory, and others.

What You’ll Bring

Education and Experience

• BSc, MSc, or PhD in a relevant discipline (e.g., biochemistry, chemistry, pharmaceutical science, biology, engineering) or equivalent experience.
• 3+ years of experience in pharmaceutical manufacturing organization and/or bioprocess development, with experience in facilities, utilities, and equipment validation.
• Excellent verbal and written communication skills, interpersonal and facilitation skills to interface with and influence all levels of the organization.
• Project management capability.
• Ability to work effectively as part of a team across all departments.
• Knowledge of quality systems, Quality by Design, validation principles for equipment, utility, and facility.

Technical Skill Requirement

• Proficiency in SAP, Veeva Vault, and strong knowledge of Excel, Word, and PowerPoint.
• Strong strategic and analytical thinking, problem solving and rapid decision‑making skills.
• Demonstrated capability in implementing challenging goals, objectives, and practices in a complex and ambiguous/matrix environment.
• Understanding of project management systems and tools; manage multiple projects and timelines concurrently; adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Experience in qualification of utilities, facilities, and processing equipment.

Our Benefits Include

• Highly competitive salary
• Annual performance‑based bonus (%)
• Share option scheme
• Group pension scheme – contribution rates (3%/5%/7%) matched by company
• 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 such as 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.

Location

Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3

Learn more about Grifols.