What are the responsibilities and job description for the Quality Engineer- Sterile Products position at Schott North America?
About us
Your Contribution
- Validation and re-validation of sterilization processes
- Lead regional or customer led improvement activities/roll-outs
- Perform trending and monitoring of KPIs pertaining to Sterile products
- Assure compliance with ISO and cGMP
- Support the laboratory side of engineering through method and equipment validation/qualification initiatives
- Manage and trend data from EM process, raw materials and finished product testing related to Sterile products
- Perform risk assessments
- Lead process mapping and continuous improvement activities
- Monitor and support the proper implementation of change controls
- Support quality control plan analysis and improvements
- Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues
- Manage assigned CAPAs
- Support experimental and validation protocols for equipment, processes and materials
Your Profile
- Bachelor's Degree in Chemistry, Microbiology, or related field, required
- Minimum (5) years of experience within a Quality Engineer role with sterile products
- Minimum (3) years of experience in product/process investigations, validations, instrument qualifications and EM programs
- Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP, preferred
- Experience in glass forming industry and/or pharmaceutical industry, preferred
- Sound computer knowledge and skills including MS Office, SAP and Minitab
Your Benefits
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Pet insurance
- Paid time off
- Other supplemental benefits available upon election
Please feel free to contact us
Your Profile
- Bachelor's Degree in Chemistry, Microbiology, or related field, required
- Minimum (5) years of experience within a Quality Engineer role with sterile products
- Minimum (3) years of experience in product/process investigations, validations, instrument qualifications and EM programs
- Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP, preferred
- Experience in glass forming industry and/or pharmaceutical industry, preferred
- Sound computer knowledge and skills including MS Office, SAP and Minitab
Your Contribution
- Validation and re-validation of sterilization processes
- Lead regional or customer led improvement activities/roll-outs
- Perform trending and monitoring of KPIs pertaining to Sterile products
- Assure compliance with ISO and cGMP
- Support the laboratory side of engineering through method and equipment validation/qualification initiatives
- Manage and trend data from EM process, raw materials and finished product testing related to Sterile products
- Perform risk assessments
- Lead process mapping and continuous improvement activities
- Monitor and support the proper implementation of change controls
- Support quality control plan analysis and improvements
- Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues
- Manage assigned CAPAs
- Support experimental and validation protocols for equipment, processes and materials
SCHOTT North America, Inc. is an Equal Opportunity/Affirmative Action Employer. Applicants considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership in any other group protected by federal, state or local law. Any form of unlawful harassment is prohibited.
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