Qualification Pilot Scientist for CMC Oral Protein Formulation (OPF)
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- Måløv
Are you passionate about compliance and qualification of production equipment? Are you eager to join a department working with processes on the edge of the future? If yes, you are the Qualification Pilot Scientist that we are looking for in OPF.
About the department
As part of Novo Nordisk’s R&D family, Chemistry, Manufacturing and Control (CMC) Development makes a real difference for patients with chronic diseases across the world. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. Our ambition is to develop break-through products based on orally available versions of GLP-1 and other proteins, such as RYBELSUS®, the first oral GLP-1 tablet on the market.
CMC Oral Protein Formulation (OPF) employs approximately 140 highly skilled people organised in six teams. Our focus is to develop and manufacture solid dose tablets for pre-clinical and clinical trial phases I and II covering a broad and exciting range of process technologies for solid dosage forms.
This role is based in the Facility Support team consisting of 20 dedicated colleagues maintaining the Facility’s “License to operate”. We are a team contributing with a broad range of skills, such as maintenance, calibration, IT, environmental monitoring and general support to ensure daily operations, and we are currently looking for you, as one of our Qualification Pilot Scientist to join our team.
The position
As Qualification Scientist, your primary focus will be performing validation/qualification of facilities and equipment for GMP use and support to process optimisation. A vital part of your job is to ensure that equipment and facilities are following cGMP standards as well as implementing development equipment. In particular, Your tasks will cover Supplier contact, Impact assessment and risk analysis, User requirement specification (URS), User instruction and Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ),Process Qualification (PQ), change request and deviation handling.
You will play a key role in our business-critical efforts to ensure and maintain the facility’s license to operate. Across your tasks and projects, you will therefore have a close collaboration with stakeholders such as End-users, Project managers, Quality Assurance and Process Groups, but most of all, our team, ensuring that our project time lines and deliverables are met.
Qualifications
You have:
- a Bachelor's or Master degree within Engineering or Pharmacy
- minimum 3 years of experience with qualification/validation of production equipment in the pharmaceutical industry.
- worked with GMP and preferably ISO,
- knowledge within solid dosage forms may be an advantage but it not a prerequisite
- skills in FMS, BMS and HVAC would be a good addition to the above-mentioned competencies
- are proficient in written as well as spoken Danish and English.
On a personal level, you:
- Are a good communicator, who shares knowledge to strengthen the overall abilities of our team. If you bring a good portion of can-do attitude and humour, we will offer a safe environment, where you can further develop your skills.
- Dare to take the lead, even when the task initially is a bit blurry.
We look forward to welcome you, in our team!
Contact
For further information, please contact teamleader Kenneth Aalbæk Jensen at +45 30753501 or Senior qualification scientist Bo Nyholm Sørensen +45 30753425
Deadline
22nd of March 2020
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Chauffør", og befinder sig i kategorien "Kontor, handel og service".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 24.1.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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