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Quality Engineer- Sterile Products

Date: Jun 1, 2021

Location: Lebanon, PA, US

Company: SCHOTT AG

International Technology Group • Specialty Glasses and Glass-Ceramics • More than 130 Years of Experience • More than 16,200 Employees in 34 countries • Innovative Ideas for the World of Tomorrow

 

What’s your next milestone?

Quality Engineer- Sterile Products

 

Our Pharmaceutical Systems Business Unit is a worldwide leader in the manufacturing of pharmaceutical primary packaging and analytical lab services.   More than 600 production lines in 13 countries globally, responsible for producing more than 10 billion syringes, vials, ampoules, cartridges and special articles of tubing glass or polymer.  We think customers, users and patients first.  We think people! 

Your Tasks

  • Validation and re-validation of sterilization processes, including new cycle development with contractor(s)
  • Lead regional or customer led improvement activities and support applicable roll-outs
  • Perform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; and implement improvement measures accordingly
  • Assure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct
  • Coordinate Environmental Monitoring (EM) program and seek potential enhancement measures to the program
  • Support the laboratory side of engineering method and equipment validation/qualification initiatives
  • Manage and trend data from EM, process, raw materials and finished product testing
  • Perform site based risk assessments
  • Monitor and support the proper implementation of change controls
  • Support quality control plan analysis and improvements, to include packaging development and execution of related projects and action items
  • Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues; provide root cause analysis and correct/preventative actions to eliminate reoccurrences
  • Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner as a result of customer complaints or customer audit findings
  • Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports

Your Profile

  • B.S. in Chemistry, Microbiology or related technical field, required
  • Minimum 5-8 years of experience in quality engineering with sterile products (ETO sterilization preferred)
  • Minimum 3-5 years of experience in product/process investigations, validations, instrument qualifications and Environmental Monitoring (EM) programs
  • Solid knowledge of ISO 9001, ISO 11135 and ISO 15378; along with cGMP
  • Experience in the glass forming industry and/or pharmaceutical industry experience, preferred
  • Thorough knowledge and experience using MS Office applications and SAP and Minitab
  • Strong technical writing and communication skills

Your Benefits

  • Healthcare benefits availalbe from first day of permanent employment, to include, medical, dental and vision insurance
  • Supplemental benefits available upon selection
  • Competitive 401K and employer match
  • Tuitiion reimbursement

As an employee of SCHOTT North America, Inc., you can anticipate challenging responsibilities and meaningful projects and tasks; centered on teamwork and cooperation throughout all levels of the Pharmaceutical Systems Business Unit.   Do you want to be a part of our team and move your career forward, while positively influencing the world around you? Then please consider applying to our position.   Your energy and innovation could be what we are looking for!

 

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. 

 

SCHOTT North America, Inc. endeavors to make our careers website accessible to all users.  If you would like to contact us regarding the accessibility of our careers website, please contact info@us.schott.com.  Any inquiries regarding employment application status, resume submittal, open position and any other general inquiries will not receive a response. 


Nearest Major Market: Harrisburg

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