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Computer System Validation (CSV) Specialist (m/f/d) for Automation

Date: Jul 13, 2021

Location: Ulm, DE, 89079

Company: Teva Pharmaceuticals

Who are we?

We want to improve the life of our patients. That is our daily mission. We are proud of our 2,500 employees who provide millions of people with essential medicines every day. And that's not all: we are represented in over 80 countries worldwide, the market leader in generics, the home of Germany's well-known pharmaceutical brand ratiopharm and a leading manufacturer of biopharmaceuticals. In total, we offer a wide range of approximately 700 products. These includes innovative drugs, generics and over-the-counter medicines.


In a nutshell: We are Teva - and we are very proud of it!


If you feel like us and if you are someone who enjoys exploring unknown paths - then we would like to get to know you. Are you also enthusiastic about global markets and technologies? And would you like to develop the future of healthcare at a leading provider of generics and biopharmaceuticals? Fantastic! Then become part of our team!


Curious? Fantastic, then take a look: https://www.youtube.com/embed/73i_f4kpfVU?rel=0&showinfo

A day in Automation

In order to ensure the supply of biopharmaceutical products for our patients, we are building a new innovative biopharmaceutical manufacturing facility at Teva's Ulm site called the Genesis Project. Our interdisciplinary team has successfully completed the detailed design of the highly automated, high-volume facility and we are now making great strides towards commissioning/qualification, technology transfer and ultimately productive use of the facility.

 

In your new role as Computer System Validation (CSV) Specialist (m/f/d) for Automation youwill support our automation team in the qualification and validation of the process control system as well as the other automation systems used to control and monitor the production process in the new building.

 

During the project phase, you will accompany the planning and concept adaptation for the validation of our process control system as well as other automation systems. Interfaces to various systems must also be considered and validated. The valid laws, guidelines and current regulatory requirements in the cGMP environment must be taken into account. This includes the independent review of cGMP-relevant documents and also the creation of documents, concepts and processes for the validation and qualification of the entire plant. This also includes coordination with the adjacent departments and coordination of tasks and responsibilities as well as the control of external supporting service providers.

 


During routine operations, you will be responsible for the validity of the automation systems together with your colleagues and will be in close contact with our Quality Assurance and all other involved departments. As an employee in the Genesis project, you will have the opportunity to work in a highly motivated, multidisciplinary team and actively help shape our processes.

 


 You can find more details about Teva Biotech in Ulm and the Genesis project at: https://www.teva.de/teva-biotech

Who are we looking for?

You are...
... a solution-oriented teamplayer?
...familiar with process control systems in pharmaceutical manufacturing, ideally in a large-scale, biotechnological multi-product plant?
...interested in ensuring the commissioning/qualification of the highly automated equipment together with the involved specialist departments in a timely manner and thus contributing an important part to the GMP-compliant operation of the new biotech plant?
...motivated to question the current status quo and to make suggestions for optimisation?


 
Do you have...
...a degree in electrical or automation engineering or a comparable field?
...very good knowledge of the applicable national and international laws and guidelines in the cGMP area with a focus on automation?
...practical experience in operating a highly automated production facility in a biopharmaceutical environment?
...extensive knowledge of the validation and qualification of automation solutions from Siemens (PCS7, Step 7, WinnCC etc.)?
...very good knowledge of  English, both written and spoken and willingness to learn German?

At Teva…

... we take care of your health (among other things through a company health management system, a company doctor, physiotherapy, sports activities and a company canteen).
... you have time for your family (through our own company kindergarten and holiday camps for school children, as well as 30 days of vacation).
... you can develop your potential to the fullest (through a comprehensive virtual training program).
... your achievements are valued accordingly (e.g. through recognition and Senior-Leaders-Programs, as well as various company events).
... we think together with you about your future (e.g. through a company pension scheme).

Function

Engineering

Reports To

Director Automation

Kontakt

Julita Mlynska
Talent Acquistion

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.