Sr. Quality Engineer (7:00am-3:00pm)

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

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 <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.

What you'll bring

<