Automation & PAT Qualification engineer

Category:  Quality
Location: 

Måløv, Capital Region of Denmark, DK

   

Do you want to be part of shaping the innovative journey in Oral Finished Product Quality Control (OFP QC)? Are you motivated by driving the Innovative and automation journey- then join us as our new Validation & Qualification engineer with Automation and PAT skills for OFP QC Team Innovation.

 

The position and responsibilities

As Validation Engineer, you will be working in a cross-disciplinary team, consisting of a broad spectrum of competencies within automation, data, PAT and equipment, where you will be helping bring laboratory automation to a GMP level of readiness. You will take a lead in validating and qualifying complex equipment, PAT, new robotic solutions/ automation projects and custom software in laboratory settings.

 

Qualifications and skills

Preferably, you have an educational background as an industrial, IT or mechanical engineering or technician, etc. You have sufficient insight in automation to lead the qualification tasks and can facilitate verification and validation activities including test execution, documentation review and approval. Ideally, you have been responsible for the development and delivery of complete validation packages, incl. IT Risk Assessment, Requirement Specifications, Validation Plan/Report (VPL/VR), Installation/Operational/Performance Qualification Protocol/Report (xQP/R), Operation and Maintenance SOPs.  

 

In addition, you have the following qualifications:

  • Experience with qualification of GAMP level 5 software GxP and FDA 21CFR part 11
  • Detail oriented mindset and quickly acquire new knowledge
  • Strong skills with validation and qualification of software and automation/robots’ projects in regulated industries
  • Experience with life cycle documentation (URS, FDS, TDS)

 

We are looking for a team-player who is dedicated and enjoy work independently and in a team. On a personal level, you are structured and skilled at knowledge sharing and you are not afraid to reach out to others for help or knowledge when relevant. You have a sincere interest in exploring innovative technologies and you enjoy being part of a team where it is important to have fun and where we work in a collaborative and trusting atmosphere.

The workplace is placed in Måløv and it is required that 3-4 days are on-site.

 

About OFP QC

Oral Finished Product (OFP) is organizationally located in Product Supply, which globally employs approx. 14.000 of Novo Nordisk more than 43.000 employees. In OFP, we are steadily growing and at present we are approximately 1100 committed colleagues in Måløv. We have great ambitions for the future, and we are working hard to get our new product successfully distributed to market.

 

The OFP QC area consist of approx. 140 dedicated colleagues newly divided in 3 departments, Market Release (release of product to market), New Product Entry and Analytical technology and Innovation.

 

Team Innovation in OFP QC is a new team in a newly created department, which gives you the opportunity to put your stamp on creating the framework and methods for how to create the best possible setup. The team consist currently of 7 colleagues and is expected to expand during 2022 to 14 dedicated colleagues.

In 2004, an ambitious and ground-breaking journey began towards becoming the world´s first pharmaceutical company to supply GLP-1-based tablets to the market. Today, many years later, we are so far that millions of patients with type 2 diabetes are able to access an oral alternative to injectable drugs. A result of the effort of skilled, innovative, and committed employees, who are proud to use their dedication to set completely new standards in diabetes treatment


Working at Novo Nordisk
At Novo Nordisk, you will help millions of people who are living with diabetes and obesity. We expect high performance and the ambition to make your mark on our business. In exchange, we offer a wide range of opportunities for professionals and personal development.

 

Contact

For further information, please contact Iben Almar Meier at + 4530792662.

 

Deadline 1st of August 2022.

 

Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

 

To ensure an efficient and fair process, please refrain from adding a photo in your CV.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.