Qualification Engineer (Pharmaceutical GMP)

Quick Facts

• Role: Qualification Engineer (m/w/d) in pharmaceutical quality/qualification

• Location: Bad Aibling, Germany

Description

You will support and lead qualification activities in a pharmaceutical environment, from planning to documentation and acceptance. The work includes risk assessments, qualification plan creation, coordination across departments, and ongoing management of quality-relevant documents and performance metrics. You will also represent qualification topics during customer audits and regulatory inspections.

Responsibilities

• Create risk analyses and qualification test/qualification plans

• Plan and conduct qualification activities, coordinating the involved specialist departments

• Perform technical review and acceptance of qualification activities and document equipment/asset acceptances

• Create, review, maintain, and evaluate quality-relevant documents

• Create, monitor, and evaluate KPIs, statistics, and trend analyses to control qualification quality

• Support and, if needed, carry out training within the area of responsibility

• Present qualification agendas during regulatory inspections and customer audits; support customer and regulatory audits

• Contribute to cross-functional projects

• Support planning and implementation of company-specific quality objectives, including technical guidance

Requirements

• Successfully completed technical degree (e.g., Pharma/Process Engineering or Chemical Engineering)

• Experience in quality assurance at a pharmaceutical company

• Relevant subject-matter expertise in qualification

• Strong can-do spirit and very high quality standards

• Proactive, solution-oriented approach to problems

• Good IT skills; solid MS Office skills

• Very good English skills (written and spoken)

Benefits

Corporate Benefits (details available in a personal conversation).