QA Engineer (m/f/d)

Role overview

Join a global pharmaceutical manufacturing business that operates under strict GMP requirements. In this position, you will support quality activities connected to engineering across manufacturing and laboratory locations. The focus is on maintaining compliance in qualification, validation, and engineering systems while meeting regulatory expectations.

What you will do

• Serve as the QA point of contact for engineering-related GMP work on site and help ensure qualification and validation activities remain compliant.
• Assess and sign off deviations, change controls, CAPAs, and validation-related variations, including the required risk evaluation and follow-up effectiveness checks.
• Assist with regulatory and client audits/inspections by preparing materials, participating in discussions, and coordinating responses for engineering topics.
• Monitor and help improve calibration and preventive maintenance systems for equipment that falls under GMP control.
• Provide quality oversight for qualification, requalification, and lifecycle activities for equipment.
• Review URS documents and contribute to defining requirements for systems and equipment.
• Review technical design documentation such as Functional Specifications and Configuration Specifications and provide quality input.
• Approve qualification protocols, completed execution records, and validation reports to GMP standards.
• Work closely with cross-functional teams to strengthen and continuously improve engineering quality processes.

Requirements

• A bachelor’s degree in Engineering, Life Sciences, or a closely related technical field.
• At least 5 years of experience in pharmaceuticals or life sciences, with no fewer than 3 years in a quality-related role.
• Strong command of English; German is an advantage.
• Solid understanding of GMP and European regulatory expectations, with knowledge of German regulations seen as a plus.
• Practical background in qualification and validation activities such as IQ, OQ, and PQ, along with computerized systems and GMP engineering processes.
• Comfort working in a busy, collaborative environment and able to solve problems effectively.
• Excellent attention to detail, strong documentation habits, and good working knowledge of Microsoft Office.

Additional information

The role is based in North Rhine-Westphalia, Germany and is a full-time onsite position. The posting does not mention salary, vacancy count, start date, or application deadline. Applicants should note that the opportunity is with a pharmaceutical manufacturing environment operating under GMP controls.

Application note

Interested candidates can apply to find out more. If this is not the right fit, sharing it within your network is also encouraged.