Lead, Validation

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your role at Baxter:

The role of the Validation Lead is to conduct, coordinate and manage project related validation activity in order that validation documentation is prepared to the necessary standards and executed in line with the overall Project Validation Master Plan for Ireland Compounding in our South Dublin Sites.

Essential Duties and Responsibilities

• Lead validation activities on specific projects including defining the validation requirements to ensure compliance and industrial guidance.

• Ability to translate local, corporate and regulatory requirements into validation requirements

• Liaise with project team members

• Change Control Management

• Ability to write User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation and / or trial purposes

• Run validation project execution IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved

• Deviation / Non- Conformance management (including RA, RCA & CA/PA).

• Proactively coordinate validation activities and act as a central point of contact for the project team for validation to ensure the projects are delivered on schedule

• Author and report validation documentation to meet regulatory and Baxter standards

• Resolve both GMP and business issues and deviations

• Plan and prioritise their work load to ensure that agreed deadlines are met.  This includes coordinating and performing validation activities, tracking and reporting the progress of activities, anticipating and removing obstacles to progress

• Provide periodic updates to the Validation Supervisor, Process QA Manager and Quality Assurance Leaders

• Ensuring validation documents are in a constant state of "audit readiness"

Qualifications

• Strong validation and install experience in relation to Facilities and Utilities in a Pharmaceutical, Medical Device or similar environment.

• Minimum: degree level education in Pharmacy, Chemistry, Microbiology, Engineering or similar or equivalent industry experience.

• Experience in Facilities and Utilities project validation to include HVAC, Cleanroom, Compressed Air etc.

• Experience in 6-Sigma and Lean Manufacturing.

“What are some of our benefits of working at Baxter?

• Pension
• Annual Bonus
• Health Insurance
• Life Assurance
• Work life Balance

#IND-UKOPS

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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