Engineer I - Maintenance Reliability

• 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
• Use technical writing skills for the implementation of CAPA records, action testing/verifications and/or implementations, mitigation actions, effectiveness check criteria
• 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) and contributing factors
• Complete all investigation phases within the required timeframe
• Develop investigation strategy by coordination of activities such as brainstorming sessions with multidisciplinary team, process observation, product (samples) evaluation, interviews, and follow-up meetings
• Assist in identifying with the multidisciplinary team the appropriate mitigation actions, Corrective and Preventive actions, and in determining the Effectiveness Check Criteria
• Execute queries and reports from electronic system, as necessary
• Perform SOP changed to improve, process or by CAPA actions
• Ensure timely follow-up of corrective and/or preventive action, monitoring CAPA process from to beginning to the end
• Promote a zero-harm workplace, and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees
• 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

• Fluent in written and spoken English
• Knowledge of Quality Systems, Trackwise electronic system preferable
• 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
• Desirable Technical Writing skills certification or equivalent
• 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

Desirable Technical Writing skills certification or equivalent

• 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