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
We are looking forward to your application.
Your SCHOTT Recruiting Team
