Quality Engineer I, QA Systems

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:

Coordinate the validation program to ensure the facility and all equipment, processes and systems are in a validated state of control, by maintaining Validation Master Plans, creating and compiling validation packages, providing technical expertise and information resources to other departments Subject Matter Expert (SME) on validation to ensure compliance to Regulatory and Corporate requirements. Create validation packages for equipment/process, computer systems and test method validations to demonstrate a validated state of control. Ensure Data Integrity elements are integrated in validations where applicable. Ensure that validation protocols are written, executed, and documented in accordance with Corporate Quality Policies and Regulatory requirements. Utilize the Trackwise system for Change Control Management practices and addressing/resolving Non-Conformances Assist Engineering and Production with commissioning activities where applicable General Expectations:

Safety:

following all safety procedures understanding potential hazards in your area wearing appropriate PPE reporting all incidents / near-misses / concerns embracing 6s

Quality:

following Good Manufacturing Practices (GMP) adhering to all quality procedures completing training on-time Doing it Right the First Time, and reporting any quality concerns immediately.

As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by: participating in improvement activities identifying and implementing continuous improvement ideas participating in Tier meetings recognizing your peers, and embracing 6s. identifying and implementing VIP’s (Value Improvement Project) embrace continuous learning utilize Leader Standard Work utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results. What you’ll be doing:

Ensure validation packages for equipment, processes, computer systems and test methods are created in a timely manner and such packages demonstrate a validated state of control Author and coordinate validation protocols, manage the execution of validation testing plans by liaising with other departments to coordinate validation activities, compile and analyze data, perform statistical analysis and prepare validation packages Coordinate validation and IQ/OQ/PQ activities with Production, Engineering, Quality Control Laboratories and outside contractors providing leadership, training and guidance Participate in any technical discussions regarding process validation, equipment qualification, and computer system validation. Assist other business functions with the: Investigational studies, Commissioning protocols, Technical Position Papers, NCR investigations Participate as the Validation SME during internal and external Regulatory and Compliance inspections Participate in change control activities and perform validation assessments within change controls. Act as a NCR/CAPA owner for validation related NCRs/CAPAs. Manage the validation status of the site VMP and ensure change control by maintaining the site Master Plan attachments’ as a current document. What you’ll be having:

Bachelor of Science or Engineering, major in Science (Chemistry, Microbiology, Pharmacy, Engineering) 2-5+ years experience in validations for a GMP regulated environment Previous experiences in GMP environment Knowledge of GMP, ISO and Regulatory standards Excellent written & oral communication skills required for assisting in commissioning protocols, technical position papers & writing validation test plans, and final reports People management experience including the ability to motivate and mentor. Experience with Health Canada requirements and inspections. Strong understanding of Health Canada GMP Regulations for equipment/process and computer software validations. Thorough knowledge of applicable procedures, specifications, regulations and standards. Strong process and project management capabilities. Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization. Ability to build strong relationships with internal and external customers. Strong ability to balance multiple priorities. Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action. Strong analytical and problem solving skills and critical thinking abilities. Intermediate to Advanced proficiency in Word, Excel, Powerpoint. Solid understanding of statistical tools/techniques Nice to have:

Experience working with pharmaceutical systems Experience with liquid processing equipment is an asset. Knowledge of Corporate Quality requirements Preferred: Intermediate knowledge of Statistical Process Control and Statistics. Certified Greenbelt designation. Ability to support our transformation to a LEAN enterprise through the application of LEAN tools. Proficiency in Trackwise System Comprehension/Proficiency of Minitab 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

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