Baxter International Inc.
Senior Quality Engineer,
Baxter International Inc., Marion, North Carolina, United States, 28752
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Senior Quality Engineer
role at
Baxter International Inc.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. Our mission is to save and sustain lives, and we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Your Role at Baxter Provide hands‑on validation support to several facilities, utilities, and equipment qualifications planned for the site. The ideal candidate will have experience in qualification of Automated Visual Inspection Systems, Automation Systems Validation, Analytical Laboratory Systems Validation (including analytical equipment), Computer Systems Validation, Formulation Equipment Qualification, Filling and Packaging Equipment, Clean Room Qualifications, and Water for Injection systems.
What You’ll Be Doing
Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter Visual Inspection of Parenterals.
Must perform process validation, process capability, and process control studies for assigned projects.
Must support Manufacturing, QC, Engineering, and Quality Management departments with the development and implementation of new process/technology.
Will participate in medium to large size projects, own the work you’re doing, and produce detailed requirements and analysis documents for work you’re leading.
Partner with other support groups and manufacturing teams to complete work.
Act as a highly effective team member.
Ensure the quality of facility systems validations.
Implement software‑driven systems while working with engineering and IT.
Maintain a basic understanding of software systems and conduct appropriate testing.
Ensure computer systems and applications follow regulatory quality standards through validation activities.
Understand and debug applicable software while following the software life cycle procedures.
Communicate effectively in written and verbal form.
Perform all other duties and responsibilities as determined by supervision/management.
What You’ll Bring
BS degree in Engineering (ME, IE, CHE, BME, EE, CE) with a minimum of 3 years of validation experience.
Critical thinker with strong interpersonal skills, self‑starter, teammate, sense of urgency, engaged, solution‑oriented.
Ability to work with a diversified multi‑functional team across different plant locations.
Self‑motivated and works well without direct supervision.
Quick learner who can understand and apply applications.
Proficient with MS Office: Word, Excel, PowerPoint, Outlook, Project.
Knowledge of Wonderware, Allen‑Bradley PLC is a plus.
Experience in Quality Assurance and/or Validation in the pharmaceutical/biotech industry is required.
IQ / OQ / PQ & Data Integrity (ALCOA).
Availability to work days, nights, holidays, and weekends as needed by the project timeline.
Physical Requirements (Large Manufacturing Site)
Continuous grasping, pushing/pulling up to 20 pounds and reaching with hands and arms.
Lifting and carrying on average up to 20 pounds frequently throughout the shift.
Normal visual acuity and the ability to distinguish color are needed.
Ability to complete quick and detailed repetitive processes using both arms and both hands.
Occasionally specialized physicals are required when working with certain drug codes.
Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance.
Compensation The estimated base salary for this position is $88,000 – $121,000 annually. This range may vary based on location, skills, expertise, experience, and other relevant factors. The position may also be eligible for discretionary bonuses.
Benefits
Medical, Dental, and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401(k) match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
US Benefits At Baxter (except for Puerto Rico) Health and life benefits start on day one, including basic life, accident, short‑term and long‑term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and the 401(k) Retirement Savings Plan (RSP) with matching. Other benefits include Flexible Spending Accounts, educational assistance, 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 (EAP), and childcare benefits.
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 you need a reasonable accommodation for any part of the application or interview process, please let us know your request.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Medical Equipment Manufacturing
#J-18808-Ljbffr
Senior Quality Engineer
role at
Baxter International Inc.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. Our mission is to save and sustain lives, and we are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Your Role at Baxter Provide hands‑on validation support to several facilities, utilities, and equipment qualifications planned for the site. The ideal candidate will have experience in qualification of Automated Visual Inspection Systems, Automation Systems Validation, Analytical Laboratory Systems Validation (including analytical equipment), Computer Systems Validation, Formulation Equipment Qualification, Filling and Packaging Equipment, Clean Room Qualifications, and Water for Injection systems.
What You’ll Be Doing
Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter Visual Inspection of Parenterals.
Must perform process validation, process capability, and process control studies for assigned projects.
Must support Manufacturing, QC, Engineering, and Quality Management departments with the development and implementation of new process/technology.
Will participate in medium to large size projects, own the work you’re doing, and produce detailed requirements and analysis documents for work you’re leading.
Partner with other support groups and manufacturing teams to complete work.
Act as a highly effective team member.
Ensure the quality of facility systems validations.
Implement software‑driven systems while working with engineering and IT.
Maintain a basic understanding of software systems and conduct appropriate testing.
Ensure computer systems and applications follow regulatory quality standards through validation activities.
Understand and debug applicable software while following the software life cycle procedures.
Communicate effectively in written and verbal form.
Perform all other duties and responsibilities as determined by supervision/management.
What You’ll Bring
BS degree in Engineering (ME, IE, CHE, BME, EE, CE) with a minimum of 3 years of validation experience.
Critical thinker with strong interpersonal skills, self‑starter, teammate, sense of urgency, engaged, solution‑oriented.
Ability to work with a diversified multi‑functional team across different plant locations.
Self‑motivated and works well without direct supervision.
Quick learner who can understand and apply applications.
Proficient with MS Office: Word, Excel, PowerPoint, Outlook, Project.
Knowledge of Wonderware, Allen‑Bradley PLC is a plus.
Experience in Quality Assurance and/or Validation in the pharmaceutical/biotech industry is required.
IQ / OQ / PQ & Data Integrity (ALCOA).
Availability to work days, nights, holidays, and weekends as needed by the project timeline.
Physical Requirements (Large Manufacturing Site)
Continuous grasping, pushing/pulling up to 20 pounds and reaching with hands and arms.
Lifting and carrying on average up to 20 pounds frequently throughout the shift.
Normal visual acuity and the ability to distinguish color are needed.
Ability to complete quick and detailed repetitive processes using both arms and both hands.
Occasionally specialized physicals are required when working with certain drug codes.
Must be able to squat, climb, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance.
Compensation The estimated base salary for this position is $88,000 – $121,000 annually. This range may vary based on location, skills, expertise, experience, and other relevant factors. The position may also be eligible for discretionary bonuses.
Benefits
Medical, Dental, and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401(k) match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
US Benefits At Baxter (except for Puerto Rico) Health and life benefits start on day one, including basic life, accident, short‑term and long‑term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) and the 401(k) Retirement Savings Plan (RSP) with matching. Other benefits include Flexible Spending Accounts, educational assistance, 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 (EAP), and childcare benefits.
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 you need a reasonable accommodation for any part of the application or interview process, please let us know your request.
Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Medical Equipment Manufacturing
#J-18808-Ljbffr