Quality Validation Engineer - Onsite Weekdays

Baxter International Inc. • Medina, NY

7d • $76,000 - $104,500 • Onsite

About The Position

Baxter is hiring a Quality Validation Engineer for its Medina, New York site. The position is designed as onsite, with an encouraged presence five days per week. The role reports to the QA Systems Manager and supports validation, change control, process improvement, audits, and cross-functional technical work in a regulated manufacturing facility. The engineer is expected to execute complex validation activities with little or no guidance, prepare technical documentation and data-driven reports, and support process design, equipment installation, qualification, and monitoring. The work environment is governed by FDA and internal quality standards, with required compliance with facility procedures and, where applicable, cleanroom or ESD protocols.

The estimated base salary is $76,000–$104,500 annually. The position may also be eligible for discretionary bonuses. Baxter states that eligible employees receive comprehensive compensation and benefits, including medical and dental coverage beginning on day one, insurance coverage, retirement and stock purchase plans, flexible spending accounts, educational assistance, time off, leave benefits, commuting benefits, employee discounts, employee assistance, and childcare benefits. Applicants must be authorized to work for any U.S. employer; visa sponsorship is not available.

Requirements

• Bachelor's degree in Engineering.
• Experience with technical communication, cross-functional collaboration, problem-solving, root cause analysis, and applying engineering principles.
• Strong multitasking and prioritization skills.
• Motivation to learn and accomplish goals.
• Ability to meet tight deadlines.
• Ability to work onsite at the Medina, New York site and regularly support the business through in-person engagement.
• Ability to sit, stand, or walk throughout the workday.
• Ability to lift and carry up to 20 pounds and perform repetitive hand and finger motions.
• Good hand-eye coordination and dexterity.
• Ability to lift 15 pounds from floor to shoulder, lift 2 pounds overhead, and push or pull with up to 6 pounds of force.
• Comply with facility rules and procedures, including wearing a static protective smock and wrist strap in designated areas and following cleanroom or ESD protocols as required.
• Must be authorized to work for any employer in the United States; visa sponsorship is unavailable.

Nice To Haves

• 1–3 years of engineering experience.
• Experience and/or training with process improvement methods such as Six Sigma or Lean.
• Interest in obtaining ASQ certifications.
• Experience in manufacturing and/or the medical device industry, including development and deployment of Quality Systems.
• Basic understanding of validation guidelines, cGMP regulations, and Good Manufacturing Practices.

Responsibilities

• Support and execute complex IQ, OQ, PQ, and MSA validation protocols and reports for facility processes, equipment, test methods, and computerized systems throughout validation stages, with little or no guidance.
• Own and drive change control according to procedural requirements.
• Assist with, present, defend, and communicate during external audits and other validation activities or projects in which the employee leads or participates.
• Assist with or lead process improvement projects, such as scrap reduction and defect reduction, with little or no guidance.
• Collaborate with cross-functional teams, including production, quality, and laboratory teams.
• Apply engineering principles and procedures, including relevant technical specialties and software-based tools.
• Assist in technical reviews and organize data and prepare appropriate documentation for assigned projects.
• Assist management or other engineers during process design, equipment installation, qualification, and process monitoring.
• Provide technical reports and data-driven analysis after training.
• Support plant initiatives through the development and implementation of new processes and technologies.
• Perform other duties as assigned.

Benefits

• Medical and dental coverage beginning on day one for eligible roles.
• Basic life, accident, short-term disability, long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan with employee contributions and company matching options.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays.
• Paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program.
• Childcare benefits.
• Potential eligibility for discretionary bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level