At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. 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. 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: The top two priorities for all Baxter Alliston employees are Safety and Quality: Safety: Support our goal to achieve a "Zero Harm Environment", by ensuring the safety of yourself and your co-workers through: following all safety procedures understanding potential hazards in your area wearing appropriate PPE reporting all incidents / near-misses / concerns embracing 6s Quality: Ensure the quality of our products to ensure patient safety and achieve our mission of "Saving and Sustaining Lives". 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.

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

Manage the validation status of the site VMP and ensure change control by maintaining the site Master Plan attachments’ as a current document

Bachelor of Science or Engineering, major in Science (Chemistry, Microbiology, Pharmacy, Engineering)

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

Experience with Health Canada requirements and inspections

Strong understanding of Health Canada GMP Regulations for equipment/process and computer software validations

Robust process and project management capabilities

Ability to build strong relationships with internal and external customers

Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action

Intermediate to Advanced proficiency in Word, Excel, Powerpoint

Solid understanding of statistical tools/techniques

Experience working with pharmaceutical systems

Experience with liquid processing equipment is an asset

Knowledge of Corporate Quality requirements

Intermediate knowledge of Statistical Process Control and Statistics

Ability to support our transformation to a LEAN enterprise through the application of LEAN tools

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.

📌 Quality Engineer I, QA Systems (Alliston)
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📍 Alliston