Principle Associate - Microbiology

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

This is where your creativity addresses challenges

The role of the Principal Associate - Microbiology is primarily responsible for completing and managing activities and continuous improvement projects which promote contamination control of the manufacturing facility, cleanrooms, and processes. Responsible for project management, coordination of activities, and SME technical support from a contamination control/sterility assurance perspective.

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.

• 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

• Support implementation of large scope projects.
• Provide Sterility Assurance SME support to cross-functional departments and teams.
• Supply to design of projects considering most recent standards from Annex I, ISO14644-1, and other guidance documents.
• Leads continuous improvement projects to implement best practices as it relates to contamination control design and processes throughout the manufacturing facility.
• Apply problem-solving tools and techniques, including corrective and preventive actions to implement quality improvements.
• Provide microbiological expertise including, but not limited to, SOPs, change control, and validations.
• Design and implement training program(s) for cleanroom behavior and contamination control practices.
• Write, review, and/or approve environmental cleaning protocols to support cleaning practices.
• Coordinate completion of environmental cleaning efficacy studies.
• Define, oversee, and improve training program(s) for clean room behavior and contamination control practices.
• Complete environmental FMEAs as needed. Assess potential environmental impact of a proposed change to facility or processes.
• Perform risk assessments for construction-based activities, including establishing project specific control plans such as containment measures as needed.
• Maintain site practices for contamination control applying training and presence on the operations floor.
• Influence operations area owners to ensure quality issues are identified and implemented to maintain compliance.
• Author and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews.
• Act as Subject Matter Expert (SME) during regulatory inspections, including working with regulatory authorities on site.
• Train, mentor, and develop less experienced colleagues within Sterility Assurance.
• Sustain a clean and safe work area using 6S principles.
• Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).

• B.S. degree in Microbiology, Biology, or related scientific discipline.
• Minimum 5 years of experience in Pharmaceutical/Medical Device Industry most of which was working in a sterility assurance role.
• Microbiology lab background experience is highly preferred.
• Extensive knowledge in aseptic technique, cleanroom behavior and practice, and cleaning methodologies and risk assessments.
• Excellent communication and project management skills.
• Demonstration of advanced understanding of quality philosophies, principles, methods, tools, and standards.
• Strong technical writing skills including authoring of study protocols/final reports, data analysis and verification.
• Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.).
• Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices.
• Must have knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to connect with other team members.
• Knowledge of standard microbiological procedures (environmental monitoring, bioburden, bacterial endotoxin testing).
• Knowledge of FDA cGMP, EU Annex-I, ISO 14644-1 standards.
• Must be able to interact with various levels in multiple departments including Quality and Operations teams.

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 $88,000-$121,000. 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 job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

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.

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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.

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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.

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