Lead, Validation

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Overview

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Engineer at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Problem Solver
Analytical Thinker
Data Driven
Solution Focused & Results Oriented
Collaborative
Innovative

Lead, Validation

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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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

“I grew up in a small coastal town in India called Bhubaneswar, where we have our own traditions and culture. I think this has helped me grow personally and professionally. Working with a global team at Baxter, my background helps me to be open, appreciate and relate to people from all different places.”

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

“I have a wonderful team. They have been flexible and open to the differences in communication methods and work style necessary for me to excel. If I didn’t have that support, I wouldn’t be where I am now and I wouldn’t have been able to advance within the company. I’m proud to work at Baxter.”

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

“My involvement with National Society of Black Engineers outside of work has afforded me the opportunity to manage Baxter’s external partnership with the organization, exposing us to networking and talent that can help drive diversity and innovation, and providing opportunities for more community engagement and involvement, which I know a lot of my colleagues like.”

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We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Lead, Validation

Overview

Success Profile

Lead, Validation

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

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

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.

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Hear from Our Employees

Meet Anwesha – recently promoted to Manager, she leads a team of software engineers for our Medication Delivery business.

Meet Sam – he has been with Baxter for over 15 years, working as an Engineering Technologist in Round Lake, IL, US.

Meet Erika – she has been an engineer in Round Lake, IL, US for over four years, promoted to Senior Principal Engineer in 2019.

Related Content

Join Our Talent Community