Qualification & Compliance Engineer (w/m/d)

Overview

Qualification & Compliance Engineer for vaccine production, supporting planning, commissioning, and qualification of process equipment. The role is fixed term for 2 years in Singen, Germany.

What you'll do

• Plan, coordinate, and execute DQ, IQ, OQ, and PQ for process systems and utilities in the vaccine context.
• Ensure compliance with local and global GMP/quality requirements for sterile and non-sterile manufacturing, filling, and packaging.
• Create, manage, and track change controls.
• Develop and implement CAPAs and handle deviation investigation, documentation, and records.
• Create, review, and maintain SOPs and quality-relevant documents.
• Conduct and document periodic reviews and support audits/inspections.

What you'll need

• Have a completed degree in pharma, process engineering, qualification, or a related field.
• Experience qualifying equipment and media systems in a GMP-regulated environment.
• Strong communication and teamwork skills, plus self-drive and willingness to act.
• High flexibility and a hands-on mindset.
• Knowledge of CAD and data integrity under 21 CFR Part 11.
• Proficiency with MS Office.
• Fluent German and English in speaking and writing.

Details

• Location: Singen, Germany.
• Employment is fixed term for 2 years; full-time employee.