Job Description

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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxters 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.

Summary

The Filling Operator position is responsible for aseptic execution of assigned activities within the Grade A/B manufacturing area; activities shall include current Good Manufacturing Practices (cGMP) compliant gowning, setup and operation of aseptic filling equipment, aseptic movement of components and fill machine equipment, and conformance to Good Documentation Practices (GDP) standards. A Filling Operator will also initiate minor revisions to existing documents and troubleshoot simple processes / equipment failures.This Filling Operator may be required to cross-train as a support Operator for additional areas.This position reports to a Manufacturing Supervisor.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned)

* Understand and follow current Good Manufacturing Practices
* Perform routine cleanup and sanitizations as assigned by area supervision to maintain cGMP compliance within the Grade A/B work areas.Perform sanitizations in a timely and effective manner in accordance with cGMPs and Baxter procedures, maintaining production schedule.
* May be required to cross train as a support operator to assist additional manufacturing areas.
* Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.
* Perform routine verification of equipment when unloading autoclaves and setting up aseptic filling machines.
* Setup and operate aseptic filling equipment for routine aseptic processes, performed with proper aseptic technique to prevent negative safety, identity, strength, purity and quality (SISPQ) impact to the batch.
* Perform routine operations utilizing aseptic formulation and filling equipment in Grade A/B areas.
* Perform environmental monitoring; including fingertip, contact, and fallout plates.Assist in the training and development of other team members on processes in which they are qualified.

Qualifications

* High school diploma or GED required
* 2 years of experience operating and troubleshooting complex production equipment preferred
* 6 months previous Pharmaceutical Manufacturing experience preferred
* Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
* There are minimum training requirements for each operator level

Physical / Safety Requirement

* Ability to stand for extended periods of time
* Ability to lift up to 50 pounds
* Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
* Must be able to perform overhead work (ie: sanitizing walls and ceilings)
* Physical coordination/flexibility to allow gowning for clean room environments
* Utilize applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
* Dexterity and physical condition to perform some level of repetitive motion tasks
* Ability to wear respirator when product or task requires
* Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
* Duties may require overtime work, including nights and weekends
* Use of hands and fingers to manipulate office equipment is required
* Must be able to gown qualify for Grade A/B areas.
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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.

EEO is the Law
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Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.