Quality Engineer

Education

(Quality Analyst II) Associate Level:

Minimum Bachelor’s degree in engineering or scientific discipline (Pharmacy/biologics, Computer Science & Engineering, Instrumentation preferred)

Experience

• Minimum 2-3 years relevant experience in Computer Systems validation and Instrument validation
  
  

Responsibilities

• Knowledge of 21CFRPart 11/ EU Annex 11/ /MHRA Data Integrity Guidance/ /ALCOA + principles
• Must be well versed with SDLC methodology
• Must have thorough knowledge of the application of GAMP5 guidelines
• Must be knowledgeable about risk-based validation and have the ability to complete risk assessments using FMEA analysis
• Excellent written and verbal communication skills in English
• Must have working knowledge of MS Word and Excel
• Knowledge of LIMS validation and Controlled Spreadsheets validation a definite advantage
• IT Quality reviews of Change control and Incident management as part of ongoing maintenance
• Periodic Reviews of all validated systems
• GxP assessments of systems
• Decommissioning and Retirements of legacy systems
• Connect with management, global CSV and business teams to understand requirements, give status reports and manage assigned deliverables within expected timelines
  
  

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.