Quality Engineer I, QA Systems, Day Shift (Monday to Friday 08:00 - 17:00)

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.

Are you ready to progress in your career with a company that prioritizes innovation, quality, and excellence? Baxter Healthcare Corporation is searching for a full-time Quality Engineer I, QA Systems, Day Shift (Monday to Friday 08:00 - 17:00). As part of this role, you will guide a dynamic team in a fast-paced manufacturing environment, utilizing groundbreaking automated equipment to ensure quality and efficiency.

Join us and be part of a team that is committed to making a difference in the healthcare industry. Your work will contribute to our mission of “Saving and Sustaining Lives”.

Major Responsibilities / Activities

• Craft IQ/OQ/PQ and validation campaigns, write protocols for equipment software validation and equipment/process/cleaning qualification.
• Ensure full compliance with data integrity requirements and computer system validation regulatory standards.
• Monitor and support the execution of validation protocols through training, facilitating, and problem-solving activities.
• Perform retrospective validation for legacy systems and processes.
• Prepare or assist in the preparation of Validation Maintenance packages.
• Support Quality technical review/approval of departmental procedural changes and validations/protocols.
• Stay current with regulatory trends and divisional issues related to your area of expertise.
• Collaborate with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.
• Prepare monthly summary/metric reports for Management Review meetings.
• Ensure completion of activities in Baxter Quality Plans and protocols, finding opportunities and crafting action plans.

Education Level

Required:

• Bachelor of Science or equivalent experience in IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems)

Preferred:

• N/A

Major Subjects / Specialties

Required:

• Science (Chemistry, Microbiology, Pharmacy, Engineering)

Preferred:

• Information Technology, Computer Science

Type of Experience

Required:

• Computer System/Software Validation experience
• Manufacturing & Quality background
• Previous experience in a GMP environment
• Knowledge of GMP, ISO, and Regulatory standards

Preferred:

• Knowledge of Corporate Quality requirements

Experience Level

Required:

• 2 – 3 years of experience in a pharmaceutical environment

Preferred:

• 5+ years of successful experience in a pharmaceutical environment

Additional Skills / Special Training / Technical Skills Required

Required:

• Strong understanding of Health Canada GMP, GAMP5, FDA, Eudralex, and Medical Device Regulations pertaining to computer software validation.
• Validation experience with computer software, SCADA systems, and PLC validation.
• Detailed knowledge of applicable procedures, specifications, regulations, and standards.
• Strong process and project management capabilities; must be able to handle complex projects.
• Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
• Ability to cultivate positive 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

Preferred:

• Strong understanding of applicable regulatory requirements for equipment/process/cleaning qualification and validation.
• PMP Courses or Certification.
• Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
• Proficiency in Trackwise System.
• Comprehension/Proficiency of Minitab.

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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