Sr. Quality Engineer (7:00am-3:00pm) Position Available In McDowell, North Carolina

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Sr. Quality Engineer (7:00am-3:00pm)
locations
Marion, North Carolina
time type
Full time
posted on
Posted 23 Days Ago
job requisition id

JR – 159383

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. 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
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 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.
What you’ll bring
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.
Physical Requirements (Large manufacturing site)
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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 – $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for 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), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter