Reporting into the Site Quality Manager, the Environmental Quality Engineer is responsible for the development, validation, and monitoring of microbiological/ particle testing that is required to support plant operations. Support and guide investigations concerning microbiological or sterilization issues. Participate with project teams to develop and maintain manufacturing and sterilization processes that address particulate matter, pyrogens and endotoxins, bioburden, and environmental monitoring of clean rooms. Participate in global company teams to ensure consistent approaches are maintained for global products, controlled environments, sterile packaging, and sterile product claims.
location: Tempe, Arizona
job type: Contract
work hours: 9 to 5
- Overall site responsibility for environmental monitoring of the cleanrooms
- Organization of the environmental monitoring of production areas and microbial monitoring or production operators. This includes initiating monitoring excursions and supporting the site regarding risk analysis, root cause and identification of appropriate CAPA
- Trend analysis and statistical analysis of environmental results
- Implementing processes and procedures to ensure on-time delivery of testing in compliance with cGMP, the relevant regulatory guidelines / industry standards and the relevant local and global safety guidelines.
- Investigation OOS / OOT results and implementing robust preventive actions.
- Support batch release for endotoxin testing (if applicable)
- Executing / supporting qualification / validation activities within the production cleanrooms and cold storage
- Supporting other functions in the business as Subject Matter Expert.
- Monthly and quarterly reporting of Quality Key Performance Indicators (KPI's) including the coordination of necessary activities to drive improvements or address adverse trends.
- Interface with other company sites with respect to sharing of best practices. Contributing to the harmonization of test methods, equipment, infrastructure, etc.
- Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
- Compliance to all site Environmental, Health and Safety requirements, training and regulations.
- Lead and manage a high performing team to deliver the defined business goals & objectives.
- Contributes to continuous process improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste within the production environment.
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Maintains a clean, orderly and safe workstation and environment at all times.
- Performs other duties as assigned based on business needs.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Exhibits regular, reliable, punctual and predictable attendance.
- Education or Equivalent Experience: Bachelor's in Life Science, Bioengineering, or related/technical discipline with emphasis on Sterilization and/or Microbiology.
- Experience: 3-5 years of experience
- Regulatory compliance in cGMP manufacturing and testing of Pharmaceutical or Medical Device Products.
- Excellent written and verbal communication skills
- Experience working with teams and influencing decisions
- Strong background in Environmental monitoring setup, routine monitoring, and cleanroom qualification and validation.
skills: CAPA, Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.