Quality Engineer I, QA Systems

Baxter International; Canada; On-site; CAD 72,000 - 108,000; Full time

Job summary

Baxter International in Canada is seeking a Quality Engineer to lead validation programs across manufacturing equipment, processes, cleaning and computerized systems. You will ensure regulatory compliance and data integrity, collaborating with Engineering, Production, and Quality to safeguard product quality.

The role requires a Bachelor's in a scientific discipline and 5+ years in validation within a GMP environment, with strong writing, analytical and cross-functional skills.

Qualifications

• Bachelor's degree in engineering, Chemistry, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline.
• 5+ years of validation experience within a GMP-regulated pharmaceutical/biotech/healthcare environment.
• Experience with equipment qualification, process validation, cleaning validation and computerized systems validation.
• Knowledge of GMP, PICs, ISO standards, and data integrity expectations.
• Strong technical writing skills for protocols, reports and validation documentation.
• Ability to manage multiple projects with cross-functional teams.
• Analytical mindset with statistical tooling experience.
• Effective communication and stakeholder management.

Responsibilities

• Lead validation programs for manufacturing equipment, processes, cleaning and computerized systems.
• Author validation protocols and reports, analyze data with statistical techniques.
• Coordinate IQ, OQ, and PQ with Engineering, Production and external vendors.
• Provide SME guidance on validation and data integrity practices.
• Support change control and CAPA activities related to validation.
• Assist in internal audits and regulatory inspections readiness.
• Drive continuous improvement of validation processes.

Skills

Validation experience

GMP knowledge

Technical writing

Cross-functional collaboration

Data integrity awareness

Analytical thinking

Regulatory compliance

Education

Bachelor's degree in engineering, Chemistry, Microbiology, Pharmacy, Life Sciences or related field

Tools

TrackWise

Minitab

ERP systems

CAPA systems

Job description

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

As a Quality Engineer, you will serve as a key technical expert responsible for ensuring manufacturing systems, equipment, and processes meet regulatory, quality, and data integrity requirements. You will lead validation initiatives that enable reliable product quality, support continuous improvement, and help maintain inspection readiness in a highly regulated healthcare manufacturing environment.

In this role, you will collaborate across multiple functions to develop and execute validation strategies, provide technical guidance, support change management activities, and help ensure the site remains compliant with Health Canada, GMP, ISO, and corporate quality standards. Your expertise will help safeguard patient safety while enabling innovation and operational excellence.

What You'll Be Doing

• Lead the development, execution, and completion of validation programs for manufacturing equipment, processes, cleaning and computerized systems to ensure a validated state of control.
• Author validation protocols and reports, analyze validation data, and apply statistical techniques to demonstrate compliance with regulatory and quality requirements.
• Partner with Engineering, Production, Quality Control, and external vendors to plan, coordinate, and execute qualification activities including IQ, OQ, and PQ protocols.
• Serve as a validation subject matter expert by providing technical guidance on process validation, cleaning validation, equipment qualification, computerized systems validation, and data integrity practices.
• Support change control and quality system activities by assessing validation impacts, contributing to investigations, and leading resolution of validation-related non-conformances and corrective actions.
• Participate in internal audits, regulatory inspections, and compliance activities while helping ensure ongoing readiness and adherence to applicable standards.
• Drive continuous improvement initiatives by identifying opportunities to strengthen validation processes, improve efficiency, and support Baxter's operational excellence objectives.

What You'll Bring

Required Qualifications

• Bachelor's degree in engineering, Chemistry, Microbiology, Pharmacy, Life Sciences, or a related scientific discipline.
• 5+ years of validation experience within a GMP-regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
• Experience executing equipment qualification, process validation, cleaning validation and computerized systems validation, or test method validation activities.
• Working knowledge of GMP regulations, PICs, ISO standards, data integrity requirements, and regulatory compliance expectations.
• Strong technical writing skills with experience developing protocols, reports, investigations, technical assessments, and validation documentation.
• Demonstrated ability to manage multiple projects while collaborating effectively with cross-functional teams.
• Strong analytical, problem-solving, and critical-thinking skills, including experience interpreting validation data and applying statistical tools.
• Effective communication and relationship-building skills with the ability to influence stakeholders across all levels of the organization.

Preferred Qualifications

• Experience supporting pharmaceutical manufacturing operations or liquid processing systems.
• Knowledge of Health Canada regulations and experience supporting regulatory inspections.
• Experience with TrackWise Change Management and CAPA systems.
• Working knowledge of Minitab, Statistical Process Control (SPC), and data analysis methodologies.
• Lean Manufacturing, Continuous Improvement, or Six Sigma Green Belt certification.
• Experience supporting commissioning activities, technical investigations, and root cause analysis initiatives.
• Familiarity with Baxter or similar corporate quality systems and validation requirements.
• Experience working with ERP systems

We understand that compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated salary range for this position is $72,080.00 - $108,120.00 CAD annually, which reflects base salary as well as estimated target payout under the Management Incentive Compensation Plan. Individual pay will be determined based upon skills, expertise and experience, and the incentive, which is contingent upon company and individual performance outcomes.

This posting is for a current existing vacancy within our organization. We are actively seeking qualified candidates to fill this open position. If you are interviewed for this position, we will advise you within 45 days of the interview as to whether or not you were successful in obtaining the position. Information submitted as part of the job application process will be kept on file for 3 years from the date of submission in accordance with legislative requirements.

As part of our recruitment process, Baxter Corporation may use AI tools to assist screening candidates and assist in evaluating candidate qualifications. All final hiring decisions are made by the hiring manager and recruitment team.

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.