Validation Engineer

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 Youll Do:

• Define execute and report qualification re-qualification and validation studies in order to establish and maintain the qualified/validated status of range of 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 (with support from senior validation team members).
• Advise systems owner 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 provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
• Participates in continuous improvement initiatives action plans to implement operational excellence and lean practices along with setting and maintaining department goals and metrics
• Generation and review of project documentation (User Requirement Specifications validation protocols reports etc.) and Standard Operating Procedures.
• Create and update Validation Master Plan (VMP) defining the approach defining the validation approach associated with each system process and the requalification requirements including study requirements and frequency.
• Completion of risk assessments and closure of corrective and preventive actions and deviations.
• 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.

• The role will require strong interaction with QA. This role involves building effective working relationships with other functional organizations such as Manufacturing Quality Assurance Quality Control Engineering Supply Chain Regulatory and others both internally and externally to the site.

What Youll 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 experience in pharmaceutical manufacturing organization and/or bioprocess development with experience in facilities utilities and equipment validation.
• Excellent verbal & written communications skills. Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.
• 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

• Be proficient in SAP Veeva Vault strong knowledge of Excel Word and PowerPoint desirable.
• 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. Management of multiple projects and timelines concurrently. Ability to 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 %
• 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 were excited to hear from you

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Location: Grange Castle International Business Park Grange Clondalkin Co. Dublin D22 K2R3

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