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Engineer I - Maintenance Reliability

https://www.baxter.com/ Logo

Baxter

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Location:
United States of America , Aibonito

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Category:

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. This person will oversee the compliance with all the regulatory requirements related to Critical Systems.

Job Responsibility:

  • Oversee the compliance with all the regulatory requirements related to Critical Systems (Water for Injection, Manufacturing Air Conditioning, Compress Air and Vacuum and process controls (Pest Control))
  • Support Engineering area in Nonconformance Investigation and audit observation related to Critical System
  • Review changes in specifications (Certification Document Reviews-CDRs) and compliance with local SOP's
  • Perform Gap assessments between GQP's, Specs and SOP's
  • Identify gaps between PMs, Pest Control, WFI and Compress Air
  • Perform or evaluated the annual review report require for the critical systems
  • Assure compliance of procedure related to utilities maintenance
  • Support in the evaluation of the observation related to Critical System under the internal and external audit process
  • OCP evaluations for validations and Non-conformance investigations
  • Responsible for execution and documentation of the non-conformance investigations to identify the root cause(s)
  • Develop investigation strategy by coordination of activities such as brainstorming sessions
  • Assist in identifying with the multidisciplinary team the appropriate mitigation actions, Corrective and Preventive actions
  • Execute queries and reports from electronic system
  • Perform SOP changed to improve, process or by CAPA actions
  • Ensure timely follow-up of corrective and/or preventive action, monitoring CAPA process
  • Promote a zero-harm workplace
  • Look for simplification in SOP's and process forms such as housekeeping, Boiler Room operation
  • Information organization and data analysis for compliance assessment, audits and investigations

Requirements:

  • Fluent in written and spoken English
  • Knowledge of Quality Systems
  • Application of Good Manufacturing Practices
  • Leadership capabilities/skills
  • Strong analytical and problem solving skills
  • Good interpersonal/communication/influencing/negotiation skills
  • Must be willing to travel occasionally
  • Knowledgeable in ISO9000 and ISO 13485 International Standards and FDA 21 CFR 820 and FDA 21 CFR 211 regulations
  • Bachelor's Degree required in Engineering filed with 0-2 years of experience

Nice to have:

  • Trackwise electronic system preferable
  • Desirable Technical Writing skills certification or equivalent
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Paid holidays
  • Paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits

Additional Information:

Job Posted:
February 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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