Process Validation Engineer

Process Validation Engineer

Location: Hamburg  (onsite, must live locally/daily commutable)  

Duration: 6 months

Hours: 40

Languages: English & German  essential 

The Process Engineer in Technical Operations Norderstedt is responsible for the support, development, documentation and validation of the entire product and process-related workflow. 

Role & Responsibilities:

Organization and implementation of process validations, including DOEs, IQ, OQ and PQ logs and reports, creation or modification of all concerned Specifications of test methods and manufacturing processes, validation of computer software and application of statistical tools to support same validation activities.  

Responsible for creating the quality and system documentation for Manufacturing processes and products from these processes.  

Preparation and implementation of risk management activities, risk assessments (pFMEA) and environmental, health and safety assessments according to internal standards and legal requirements.  

Conducting and supporting error investigations in the case of non-conformities together with the people responsible for process quality and implementation of corrective and preventive actions (CAPA) as a team member or CAPA leader. 

Responsible for establishing calibration requirements and the Overall suitability of measuring instruments used in manufacturing and testing processes according to the relevant standards and quality regulations. 

Development, updating and validation of test methods used by production and Laboratory employees in the manufacture and validation of products and at Storage stability studies are to be applied.

Key Skills:

Microsoft Office

German & English fluent, all documentation is in English

Strong Analytical Thinking

Lean Six Sigma certification

Basic Quality Knowledge (product audits pharma and medtec)

Engineering degree 

You are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Johnson & Johnson

As the science of human health and well-being has grown, we've been able to grow with it. Even more important, we've helped shape and define what health and well-being means in everyday lives. Our products, services and ideas now touch the lives of at least one billion people every day. We credit our strength and endurance to a consistent approach to managing our business, and to the character of our people.

Application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.