Packaging Validation Associate II

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.

Your role at Baxter:

The Technical Services Packaging Validation Associate II supports all aspects of packaging equipment, including design, specification development, installation, qualification, validation and operational support. This role serves as a resource and subject matter expert for Automated Inspection Machine Equipment, Serialization and High Speed Packaging Equipment.

What you’ll be doing:

• Manages multiple projects providing technical support for packaging operations while working in a cross-functional team environment
• Identifies and implements essential changes to Automated Inspection Machines
• Performs and supports validations of Packaging equipment, Serialization equipment and Automated Inspection Machines for Syringes, Vials, and Cartridges
• Selects packaging material; conducts packaging component evaluations in terms of functionality and machinability; develops Bill of Materials (BOM).
• Develops material testing documentation including Process Flow Diagrams, Failure Mode Effects Analysis (FMEAs), Protocols, Final Reports, Standard Operating Procedures (SOPs), etc.
• Assists Engineering Department on Factory Acceptance Tests (FAT) and User Requirement Specifications (URS)
• Leads small project teams to accomplish project objectives, including creating timelines, tracking deliverables and presenting status updates to key stakeholders
• Formulates and recommends validation procedures and technical work in accordance with project and business objectives
• Applies Engineering and Quality tools to solve problems (e.g., FMEA, Design of Experiments)
• Creates project timelines and develops all related packaging equipment validation documentation
• Participates in internal and external audits
• Maintains up to date knowledge of industry requirements and practices as they relate to packaging equipment.
• Participates in client tours
• Acts as Change Control Management (CCM) Owner and authors Non-Conformance Investigations
• Reviews and Approves FSS, Line Record, Validation and SOP workflows

What you’ll bring:

• Bachelor’s degree required, science or engineering related area preferred
• Minimum of 2 years’ experience in a technical capacity working in a cGMP environment is required
• Knowledge of regulatory requirements related to packaging preferred
• Experience in machine vision preferred (Cognex and Visio is desirable)
• Serialization experience preferred
• Proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Trackwise, etc.)
• Background in validation (IQ/OQ/PQ) including study design, and the development of Protocols, Final Reports, and SOPs etc. preferred
• Ability to review Equipment Manuals including Engineering Equipment Drawings and Electrical Schematic Diagrams.
• Manages time effectively and independently within assigned responsibilities
• Possesses good leadership skills including ability to lead cross-functional departments in the implementation of new systems and modification of existing ones

Physical / Safety Requirements:

• Must be able to lift up to 25 lbs.
• Duties may require overtime work, including nights and weekends
• Use of hands and fingers to manipulate office equipment is required
• Position requires sitting/standing for long hours, but may involve walking or standing for periods of time
• Must be able to wear appropriate Personal Protective Equipment as applicable

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. To that end, this position has a salary range of $60,000 to $132,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position. The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

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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.

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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

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