Quality Engineer – Sterile Products

About the role

As a Quality Engineer for sterile products at SCHOTT Pharma, you will ensure that sterilization processes and related manufacturing activities meet the highest quality and regulatory standards. You will work closely with cross‑functional teams to drive continuous improvement and support product releases worldwide.

Key responsibilities

• Validate and re‑validate sterilization processes and related equipment.
• Lead regional or customer‑driven improvement projects and support roll‑outs.
• Trend and monitor quality KPIs for sterile products, implementing corrective actions as needed.
• Ensure compliance with ISO 9001, ISO 13485, ISO 15378, cGMP and internal policies.
• Support laboratory engineering through method and equipment validation/qualification.
• Manage data from environmental monitoring, raw materials and finished‑product testing.
• Conduct site‑based risk assessments and lead Lean‑based process mapping initiatives.
• Coordinate change controls, CAPA investigations and root‑cause analyses for customer complaints and audit findings.
• Develop and document best‑practice procedures and technical reports.

Required profile

• Bachelor’s degree in Chemistry, Microbiology or a related field.
• Minimum 5 years of experience as a Quality Engineer working with sterile products.
• At least 3 years of experience in investigations, validations, instrument qualifications and environmental monitoring programs.
• Strong knowledge of ISO standards (9001, 13485, 15378) and cGMP.
• Experience in the pharmaceutical or glass‑forming industry is preferred.
• Excellent analytical, decision‑making and communication skills.

Required skills

• ISO 9001
• ISO 13485
• ISO 15378
• cGMP
• MS Office
• SAP
• Minitab
• Lean principles