Quality Engineer- Sterile Products

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