Company: Baxter
Job description: 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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxters 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.
Your Role at Baxter
This is where your creativity addresses challenges
Provide hands on validation support to several facilities/utility and equipment qualifications that are planned for the site. The ideal candidate will have experience in one or more of the following areas: 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.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
What we offer from Day One
- Medical, Dental and Vision coverage
- 160 hours of Paid Time Off and Paid Holidays
- 401K match
- Employee Stock Purchase Program
- Paid Parental Leave
- Tuition Reimbursement
- Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation and USP Chapter <1790> 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 and participate in medium to large size projects, own work you're doing, produce detailed requirements and analysis documents for work you're leading.
- Partner with other support groups and manufacturing teams to complete work.
- Ability to function optimally as a member of a team.
- Responsible for ensuring the quality of facility systems validations: Writing and implementing protocols and test cases for validations. Coordinating testing and documentation of projects. Documenting/completing changes to applications. Assisting/leading training for systems. Develop test requirements and prepare and document test data for complex system testing. Provide support to resolve technical issues with systems under validation.
- This position will be implementing software driven systems while working with engineering and IT.
- The basic understanding of software systems and how to appropriately test is mandatory.
- Must ensure computer systems and applications follow regulatory quality standards through validations activities.
- Must be able to understand and debug applicable software while following the software life cycle procedures.
- Ability to communicate optimally in written and verbal form.
- Must perform all other duties and responsibilities as determined by supervision/management.
- BS degree in Engineering Subject area (ME, IE, CHE, BME, EE, CE) with a minimum of 3 years of validation experience.
- Soft Skills: Critical thinker, communication 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.
- Ability to quickly learn and understand applications.
- Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project, and other business applications.
- Wonderware, Allen-Bradley PLC, nice to have but not required.
- Quality Assurance and/or Validation in the pharmaceutical/Biotech industry experience is required.
- IQ / OQ / PQ & Data Integrity (ALCOA)
- Ability to work days, nights, holidays, and/or weekends as needed by the project timeline to meet manufacturing deadlines and facility shutdown/maintenance periods.
- Requires 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.
- Have the 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.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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 here and let us know the nature of your request along with your contact information.
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 . 102710
Expected salary: $60000 - 132000 per year
Location: Marion, NC Apply Now