Validation Associate

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

The Validation Associate (II) will support system owners with the generation and management of documentation associated with instrument validation and qualification activities. This person will focus on laboratory equipment and instrument systems (LE&IS) utilized in the engineering, chemistry, and information technology areas. Will be responsible for all activities performed in compliance with internal Baxter Quality System procedures and international/national regulations.

Essential Duties & Responsibilities

• Applies knowledge or quickly learns cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
• Serves as project lead with projects of intermediate scope and cross-functional teams.
• Applies knowledge of FDA 21 CFR Part 11, GAMP5 and Data Integrity to analytical instrument validation
• Develops the following validation deliverables – Risk Management Reports, Change Controls, Regulatory Assessments, 21 CFR Part 11 Assessments, Validation Plans, Qualification reports and other related documents required per SOP
• Incumbent will be responsible for the management and archiving of approved package documents
• Mentors and provides leadership to junior team members
• Handles routine tasks timely, accurately

Qualifications

• Basic Knowledge about industry GMP/GDP
• Expertise with Instrument/Equipment validations
• Proficient in MS Word and Excel, Computer software
• Well organized & able to multi-task
• Team oriented
• Analytical mindset
• Able to summarize and easily explain complex situations
• Solid verbal and written communication skills, including technical/business writing

Education & Experience

• BS in relevant Engineering/Science field
• Other degrees acceptable with 3-5 years of relevant and recent validation/qualification experience
• 3 years in GMP-regulated industry, preferably medical device or pharmaceutical
• 2 years’ experience performing instrument validations
• Knowledge of GAMP is required
• Data integrity

#LI-BAXGEN

#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement 
Pay Transparency Policy

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.

Qualifications: