commissioning & qualification engineer.

Within the Metrology and Validation department in Analytical R&D (AR&D),we are currently looking  for a scientist or engineer with a background in Commissioning & Qualification or Computer System Validation (CSV). The candidate will work at the local site and in alignment with our global Metrology and Validation team, with our counterparts in the U.S., and Ireland. The position offers development potential and responsibilities can be adjusted to the candidate’s qualifications and ambitions.

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.

 

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 needs

• Support site-wide projects and initiatives directly related to Metrology & Validation and/or AR&D

 

Day in the job:

 

• Coordination with cross-functional teams to qualify new equipment and instruments

• Coordinate and conduct maintenance and calibration of analytical equipment

• Check and evaluate potential alarms of controlled-temperature units (i.e. stability chambers) and Lab equipment

• Author SOPs, Change controls, and period review documents for equipment and instruments

• Author and Support deviation investigations

• Typical start date between 7:00 and 8:45 am

 

Your profile: 

Education – candidate could have one of the following:

• 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

 

Experience and skills:

Required:

• Strong oral and written communication skills in English (B1) and German (B2)

• 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

 

Nice to have :

• 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

Sounds interesting? Apply now – we’re looking forward to receiving your applications!