Job ID: 12438

Quality Engineering Specialist - CAPEX (m/f/d)

Entourage is a life sciences consulting firm headquartered in Munich, with additional offices in Basel, Milan, and Boston. The company features a multidisciplinary team of over 180 industry-experienced consultants who collaborate closely with leaders in the pharmaceutical and medical products industries to develop tailored solutions. Leveraging its unique hybrid approach, which combines project and management consulting, Entourage is able to offer its clients individualized solutions in the life sciences sector.

Entourage. Job offer.

Place: Stone

Job type.

Project Consulting

Your tasks.

  • Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
  • Ensuring Commissioning and Qualification (C&Q) compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
  • Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
  • Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
  • Providing leadership and guidance to project team members on C&Q strategy and issues
  • Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
  • Escalating issues in an open and timely manner and take leadership for their resolution

Your requirement profile.

  • Bachelor or Master's degree in engineering, life sciences or related field
  • Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
  • Experience in a QA role for the Commissioning and Qualification of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
  • Fluent in English, German would be an advantage

Advantages.

  • A permanent and unlimited contract with the Entourage
  • internal career and development model
  • Annual budget for further training and further education
  • Internal contact person for topics relating to project assignments and further development opportunities

Salary.

From: Not specified
Until: Not specified

Region. Category. Discipline.

Application. Advantages.

Not found a suitable job?

FAQ. Applicants.

Apply anyway! We will then decide together whether it is worth applying. If not, we will look for another job together that fits your needs and qualifications.

For the most part already. However, there are also jobs that are not yet online. So if you don't find a job that suits you, it's still worth sending us a speculative application or simply giving us a call.

Of course we do! Even if no suitable position is advertised online, we may still have a suitable position for you.
Send us an unsolicited application or give us a call: together we will discuss everything else.

Project Consultants are permanent employees of Entourage who work for clients on temporary projects. As soon as the project is finished, there is either the possibility that the customer takes over the Project Consultant in a permanent position or the Consultant continues to work for Entourage in a new project.

It's always worth contacting us. Even if you're not looking for a new job yet. Together we can explore possibilities and opportunities and determine your current market value.

No, that is not necessary! It is sufficient if you apply for one of the positions and indicate in your message that there are other positions you are interested in. Our staff will then take care of everything else.

You should always keep us informed as to whether you have applied for jobs independently or through another recruitment agency.

After you have sent us your complete application, the responsible employee will look through your documents and then get in touch with you. Either by e-mail or by phone.
In the first phone call, you will talk about your wishes and goals and make an initial assessment of whether and which jobs from our range are suitable for you.
In a further conversation, the sales consultant responsible for the company will talk to you and check whether you are suitable for the position. In this way, we can guarantee with a high degree of probability that you will sign the contract at the end of the application process.
After that, it's straight into the application phase. We forward all the necessary information to the company and keep you informed about interview dates.
Once an interview date has been set, we will prepare you for the upcoming interview in the best possible way.

It all depends on you and your preferences and wishes.
The classic permanent position offers you a permanent job with one of our clients.
Project consulting is always limited to the corresponding project with our client. Depending on the project, it can be 6, 12 or 24 months. After completion of the project, it may be that the client extends the project. If this is not the case, we will work with you to find a follow-up project that meets your expectations.

No, our work is free of charge for you as an applicant throughout all stages of the application process.

The easiest way to apply is via our application form. Either directly to the position you want or as a speculative application.
This way, the consultant in charge knows directly which position you are applying for and can look at your documents before contacting you.
As soon as your CV and other documents such as references and certificates are available, our consultants can start working and find a suitable position for you.

The most important thing for us is an up-to-date CV. In addition, your name, telephone number and/or email address are important so that we can reach you.
Other documents such as certificates, references, cover letters and the like can also be submitted later if necessary. However, it does not hurt to include all relevant information directly in the application.

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Before we pass on a person's data, we always clarify whether the person agrees to this. 

We store our customers' data on secure servers within Germany.