Job Title: Senior Quality Engineer – Validation
Req ID: JR-185976
Location: Ahmedabad, Gujarat, India
Department: Quality
Company: Baxter
About Baxter
At Baxter, we believe that every person—regardless of background—deserves the opportunity to live a healthy life. Since our founding in 1931, this core belief has guided our purpose to save and sustain lives.
Quality is central to everything we do. Our Quality team ensures patient safety and regulatory compliance across the entire product lifecycle, working collaboratively with manufacturing, R&D, engineering, and other departments.
Joining Baxter means joining a culture of courage, trust, and collaboration, where every employee is empowered to make a meaningful impact.
Here, you’ll find purpose, pride, and a career that truly matters.
Role Overview
The Senior Quality Engineer – Validation is responsible for ensuring that all equipment, systems, utilities, and processes at the manufacturing site are validated, compliant, and maintained as per cGMP, global regulatory, and Baxter quality standards.
This role ensures that the validation lifecycle—including qualification, requalification, and revalidation—is effectively managed to maintain a state of control and compliance.
Key Responsibilities (Illustrative – based on Baxter’s validation function scope)
Validation & Qualification
Lead and execute validation activities for equipment, utilities, facilities, and computerized systems.
Prepare, review, and approve Validation Master Plans (VMPs), Protocols (IQ/OQ/PQ), and Reports in accordance with global quality standards.
Ensure risk-based validation approaches following GAMP and regulatory guidance (e.g., FDA, EU, WHO).
Manage revalidation schedules and ensure timely execution.
Participate in the commissioning and qualification of new equipment or systems.
Compliance & Documentation
Ensure validation documentation meets data integrity and traceability requirements.
Maintain validation files and records in compliance with Baxter’s Quality Management System (QMS).
Review Change Controls (CC), Deviation Reports, and CAPAs related to validation activities.
Support internal and external audits by providing validation-related documentation and justifications.
Cross-functional Collaboration
Work closely with Engineering, Manufacturing, Regulatory Affairs, and Quality Assurance to ensure process control and regulatory compliance.
Provide technical guidance to cross-functional teams during equipment qualification and process validation stages.
Support continuous improvement initiatives to enhance process robustness and efficiency.
Training & Continuous Improvement
Train team members and stakeholders on validation requirements and procedures.
Stay updated with global validation regulations and ensure site-level alignment.
Drive continuous improvement in validation processes using modern tools and risk-based methodologies.
Key Attributes for Success
Detail-Oriented: Precision in documentation and validation protocols.
Collaborative: Works effectively with cross-functional teams.
Analytical: Strong problem-solving and critical-thinking skills.
Courageous & Continuous Learner: Open to challenges and committed to professional growth.
Influential: Capable of driving compliance culture across the organization.
Employee Benefits
Support for Parents and Families
Continuing Education / Professional Development Opportunities
Comprehensive Health & Well-being Benefits
Paid Time Off (PTO)
2 Volunteer Days per Year to give back to the community
Equal Employment Opportunity
Baxter is an Equal Opportunity Employer.
Qualified applicants are considered without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, or disability.
Reasonable Accommodations
Baxter provides reasonable accommodations to individuals with disabilities during the application or interview process.
If you need assistance, please contact Baxter through the provided link and share your request and contact details.
Recruitment Fraud Notice
Be alert to fraudulent recruitment activities falsely claiming to represent Baxter.
Review the official Recruitment Fraud Notice on Baxter’s Careers site to learn how to protect yourself.
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