CQV Engineer m​/w​/d

Overview

The Commissioning & Qualification Engineer role in the Metrology & Validation department,

oversees and supports the qualification of analytical instrumentation and Computer Systems

projects within the GMP environment. Responsibility of this function is to maintain the

analytical laboratories and implement new systems in a state of permanent inspection

readiness.

Project title: Commissioning & Qualification Engineer m/w/d

Type of employment: Payroll

Skills: CQV

Project start: 12.01.2026

Main areas of responsibility include:

• Coordinate and conduct equipment qualifications, validations and additional system lifecycle activities (i.e. purchasing, maintenance, decommissioning, etc.)
• System validation:
  Perform SDLC (Software development life cycle) validation in cooperation with IT and validation unit of the site
• Analytical Metrology:
  Together with the site Laboratory Asset Management Program (LAMP) coordinators, ensure calibration maintenance services are scheduled in accordance with documented due dates or ad-hoc as required to support business needsds
• Support site-wide projects and initiatives directly related to Metrology & Validation and/or AR&D

• Strong oral and written communication skills in English (B2) and German (C1)
• Strong documentation skills on technical documents, attention to detail
• Demonstrated ability for taking initiative and innovative problem solving in collaboration with other team members
• Daily communication and coordination with laboratory colleagues and managers on open tasks
• Ability to work independently and within a cross-functional team to deliver on timelines in a dynamic environment
• Experience with Commissioning/Qualification and or CSV
• Experience with controlled-temperature units and incubators, i.e. qualification, maintenance, calibration
• Experience as technical support and maintenance of manufacturing equipment
• Experience with Change Management principals and Deviation/CAPA management
• Affinity for technical maintenance of equipment and IT related software
• Experience in GMP environment, especially in GMP laboratories
• Experience in Auditing and Compliance within the pharmaceutical industry
• Thorough understanding of GMP policies and procedures and proven experience working with Quality

• Technical education (Apprenticeship) in Biotech, Pharmaceutical industry, IT or related areas
• Technical education in management and maintenance of industrial equipment
• University degree, in analytical chemistry/biotechnology/biochemistry or related field