Principal Aseptic Process Engineer

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

The Principle Aseptic Process Engineer is responsible for the design and support of Aseptic Manufacturing, risk management, process validations, equipment qualifications, MVP and any assigned areas to all government regulations, company policies and procedures. This includes supporting planning and execution of key aseptic related projects such as but not limited to: Production process/systems implementation, shut down/restart process, media fill oversight, deviation investigations and change management.

The role requires taking decisions based on data, information, and input from Subject Matter Experts (SMEs), cGMP expectations, Baxter’s Quality System, while applying risk management principles. The person in this role must ensure a timely escalation of significant quality issues to the Quality Management Representative (QMR) and Plant Manager.

This candidate must be able to work cross-functionally with Quality, Operation, Maintenance, Validation, and Sterility Assurance to deliver key milestones for projects.

Your Team

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 value both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to build top-of-the-line products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What we offer from day 1:

• Vacation and Paid Holidays
• Medical, Dental, Disability and Life Insurance coverage
• Vision and Voluntary Benefits
• Paid Parental Leave
• Retirement Savings Plan – 165E
• Employee Stock Purchase Program
• Educational Assistance Plan

What you'll be doing

• Responsible to ensure timely delivery of assigned programs providing end-to-end quality oversight including but not limited to aseptic process, risk management, MVP, validations process, etc.
• Lead site qualifications and continuous process validations from a quality perspective to ensure requirements are met.
• Provide mentorship and technical expertise of regulatory in Risk Management strategies and processes.
• Assess risks associated with non-conformances complaints, audits, change control etc. and ensure the site process FMEA is evaluated and updated as needed to include new risks.
• Handles activities to maintain site Master Validation Plan.
• Leads the Technical Services team to ensure site validations activities are performed in compliance with regulations and corporate requirements.
• Participates in audits as Subject Matter Expert of the designated areas in addition to encouraging the team to participate in audits.
• Oversee adherence of project milestones to be able to comply with the established projects goals.
• Must keep work area in the cleanest and most orderly conditions.
• Performs visits to areas of responsibility, document findings and suggestions to improve processes.
• Revises, implements changes and audits existing specifications and SOPs; creates new ones as required.
• Develops and implements procedures on established policies.
• 21 CFR Regulations compliance oriented.
• Safety Regulations OSHA compliance oriented

What you'll bring

•  Bachelor’s degree (BS) in industrial, mechanical, chemical, or electrical engineering; with 5 – 8 years proven experience.  At least 5 years of experience in aseptic pharmaceutical manufacturing and/or quality environment. 
• Experienced in the manufacturing, handling and testing of Aseptic products, and any of the specific manufacturing technologies used in the site’s manufacturing operations, to ensure compliance with cGMP. Experience in equipment, process, systems and or computerized systems validation. CQE (desirable). ISO 14644 current version and 21 CFR Regulation Part 210 and 211 or Part 820 (desirable). Excellent communication skills. Lean/Six Sigma tools knowledge (preferred).

• Fully bilingual (written and oral), English and Spanish languages. Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations.  Ability to write reports and procedure manuals.  Ability to optimally present information and respond to questions from groups of managers, internal or external audits, customers, immediate supervisor, and the general public. 

• cGMP's and other training courses, certificates or licenses as per business needs.

• Green Belt certified desirable.

• Ability to apply sophisticated mathematical concepts such as exponents, logarithms, quadratic equations, and permutations, operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Knowledge of statistical software and calculations.

Reasoning ability

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Ability to deal with problems involving several concrete variables in standardized situations. Technical writing and reporting skills.

• Observes and promotes company security, industrial hygiene, cGMP’s, procedures and other security measures already established by the company.

Physical Demands

While performing the duties of this job, the employee must occasionally lift and/or move up to 20 pounds. Noise level in the work environment is usually moderate. Reasonable accommodation maybe made to enable individuals with disabilities to perform the essential functions.

Work Environment

While performing the duties of this job, the employee is occasionally exposed to wet and/or humid Conditions; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; outside Weather conditions; extreme heat; and vibration. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Safety Equipment and / or Equipment

The employee is required to use the appropriate Safety Equipment that Baxter requires to align with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, uniform, special safety suits, gloves, and any other equipment vital to protect the health and safety of the employee. The incumbent must be able to use industrial and non-industrial

Computerized system; manufacturing and laboratory equipment; telephone; office supply; copy machine; fax machine; computer as required.

Disclaimer Statement

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as a comprehensive list of all responsibilities, duties and skills required of personnel so classified.

Join our dedicated team at Baxter Healthcare Corporation and be part of our mission to improve healthcare outcomes for patients worldwide. Apply today and take the next step in your career!

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

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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 link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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