Quality Engineer Sterile Products

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 offPet insurance  Other supplemental benefits available upon election

Please feel free to contact us