What are the responsibilities and job description for the Quality Engineer Sterile Products position at Schott North America?
About us
Human health matters. SCHOTT Pharma designs science-based solutions to ensure medications are safe and easy to use globally. A team of 4,700 people from over 60 nations contributes to global healthcare. With 17 sites worldwide, the company is headquartered in Mainz, Germany, listed on the Frankfurt Stock Exchange, and committed to sustainable development for society and the environment.
Your Contribution
- Validation and re-validation of sterilization processes
- Lead regional or customer led improvement activities and support applicable rollouts
- Perform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; 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/safety guidelines
- 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 reltated to Sterile products
- Perform site based risk assessments
- Lead process mapping and continuous improvement activities using Lean principles and tools
- Monitor and support the proper implementation of change controls
- Support quality control plan analysis and improvements, including 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 corrective/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 resulting from customer complaints, internal or customer audit findings
- Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
- Develop and document best practice methods; ensure standardized procedures
- Participate in required trainings and meetings, when necessary
- Help promote and implement safety/EHS directives and maintain a clean and safe workspace
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
- Multi-tasking abilities and prioritization
- Detail oriented approach; service oriented
- Decision making skills
- Forward and creative thinking
- Analytical/critical thinking
- Effective communication skills
- Ability to read, write and speak English language
Your Benefits
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Paid time off
- Pet insurance
- 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
- Multi-tasking abilities and prioritization
- Detail oriented approach; service oriented
- Decision making skills
- Forward and creative thinking
- Analytical/critical thinking
- Effective communication skills
- Ability to read, write and speak English language
Your Contribution
- Validation and re-validation of sterilization processes
- Lead regional or customer led improvement activities and support applicable rollouts
- Perform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; 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/safety guidelines
- 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 reltated to Sterile products
- Perform site based risk assessments
- Lead process mapping and continuous improvement activities using Lean principles and tools
- Monitor and support the proper implementation of change controls
- Support quality control plan analysis and improvements, including 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 corrective/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 resulting from customer complaints, internal or customer audit findings
- Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
- Develop and document best practice methods; ensure standardized procedures
- Participate in required trainings and meetings, when necessary
- Help promote and implement safety/EHS directives and maintain a clean and safe workspace
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.