Senior Sterilization Process Expert

7 days ago


Lebanon, Pennsylvania, United States Schott North America Full time

At Schott North America, we are seeking a highly skilled Senior Sterilization Process Expert to join our team. This is an exciting opportunity for someone who is passionate about quality and has a strong background in sterile products.

About the Role

We are looking for an experienced Quality Engineer with a proven track record in sterilization process validation and compliance. The successful candidate will be responsible for leading regional or customer-led improvement activities, performing trending and monitoring of KPIs, and ensuring compliance with ISO and cGMP regulations.

Key Responsibilities
  • Validate and re-validate sterilization processes to ensure their effectiveness and efficiency
  • Lead regional or customer-led improvement activities to drive continuous process improvements
  • Monitor and trend key performance indicators (KPIs) related to sterile products to identify areas for improvement
  • Ensure compliance with ISO 9001, 13485, and 15378 standards, as well as cGMP regulations
  • Support laboratory engineering initiatives through method and equipment validation/qualification
  • Manage and trend data from EM processes, raw materials, and finished product testing related to sterile products
  • Perform risk assessments to identify potential hazards and develop mitigation strategies
  • Lead process mapping and continuous improvement activities to optimize business processes
  • Monitor and support the implementation of change controls to ensure regulatory compliance
  • Support quality control plan analysis and improvements to ensure accurate and reliable results
About You
  • Bachelor's Degree in Chemistry, Microbiology, or a related field is required
  • A minimum of 5 years of experience in a Quality Engineer role with sterile products is necessary
  • Minimum 3 years of experience in product/process investigations, validations, instrument qualifications, and EM programs is required
  • Solid knowledge of ISO 9001, 13485, and 15378, along with cGMP, is preferred
  • Experience in the glass forming industry and/or pharmaceutical industry is also preferred
  • Sound computer knowledge and skills, including MS Office, SAP, and Minitab, are essential
What We Offer
  • An estimated salary range of $90,000 - $120,000 per year, based on location and experience
  • Excellent healthcare benefits, including medical, dental, and vision coverage
  • Short and long-term disability insurance
  • Tuition reimbursement
  • Pet insurance
  • Paid time off
  • Other supplemental benefits available upon election

If you are a motivated and detail-oriented individual with a passion for quality and sterile products, we encourage you to apply for this exciting opportunity.



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