Sterility Associate I
: Job Details :

This is where you save and sustain lives

To be considered for an interview, please make sure your application is full in line with the job specs as found below.

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

As the site Sterility Associate, you will serve as the primary resource for the team and support development, validation and maintenance of sterilization processes and cleanroom certification. This position plays a substantial role in the qualification and/or validation of sterilization, cleanroom, equipment, raw materials, and manufacturing processes. In this role you will directly impact the health and safety of our end-users, our patients.

Your team

The Quality Team is comprised of inquisitive individuals who adopt a collaborative approach and tackle sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment.

We provide opportunities for you to continue to learn through training, conferences, certifications, and support for advanced degrees. Growth from role to role or level to level is encouraged and is supported by management to ensure employees are consistently engaged with their work. Our benefits enable you to better yourself and plan for your future as we offer tuition reimbursement, a generous 401k match program, and comprehensive health benefits for you and others who count on you.

What you'll be doing

• Apply knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Perform a variety of projects/studies in areas that may include Product/Process, sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations.
• Maintain sterilization of products through annual re-validation, dose audits, and bioburden monitoring.
• Develop and validate sterilization processes for new and existing products.
• Serve as project lead with projects of intermediate scope and multi-functional teams.
• Qualify, maintain, and tackle multi-layered problems related to the sterilization of products and associated equipment.
• Review and evaluate non-conformances, performing root cause analysis, and proposing corrective/preventive actions.
• Generate and update engineering documents such as manufacturing/quality instructions, test methods, and test protocols/reports.
• Connect with different functional groups and producing appropriate documentation in support of projects.

Other important factors

• This is an onsite position
• Some work for this role will be performed in controlled environment areas.
• Maintain reliable attendance
• Complete trainings in a timely manner
• Contribute to a positive work environment

What you'll bring

• BS Degree in Science, Engineering or Math or other relevant field with 1+ years of proven experience.
• 1+ years in medical device or pharma industry required.
• Sterility assurance or sterilization operations experience preferred
• Proven track record of communicating at all levels in verbal and written form, including technical/business writing.

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