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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