Validation Engineer

NorthX Biologics is a Contract Development and Manufacturing Organization that offer services and support in the development and manufacturing of biologics used in vaccines, gene/cell therapy and other advanced applications. We have a long tradition of pharmaceutical manufacturing and have been manufacturing GMP biologics since 1992. In 2021 we were recognized as a national innovation hub for advanced therapeutics and vaccines and have expanded our development capabilities to serve our clients. This includes a new development organization with cutting edge laboratories and technologies.
 
We are now looking for a Validation Engineer to join our operation/project Team. The position is located in Matfors and will from time-to-time travel to our site in Stockholm. The position can partly be performed remotely. Starting date at the earliest convenience but we are willing to wait for the right person.  
 
You will be working with scientific tasks to prove that our rooms, equipment and processes are functional as intended, e.g. Validation. You will be working with validations to establish new production/process lines as well as recurrent revalidations of sterilizing processes and rooms. As a contract manufacturer we are constantly adding new equipment and additional cleanroom modification. As such, broad experience from validations and/or manufacturing of biopharmaceuticals is an advantage.
 
We expected that applicants have a university degree suitable for working in the Biopharmaceutical industry or an extensive experience that is comparable. For this recruitment we prefer senior/experienced candidates that are willing to take responsibility for our validation routine. As the sites only validation engineer you must be fine in supporting other scientists/engineers in their validation work.  
 
Technical skills that are meriting are listed below.
 
·       Validation of equipment, rooms, computerized systems, and processes.
·       Cell Culture / Fermentation

Purification of biologics


Manufacturing of biopharmaceuticals for phase I/II


Examples of daily work tasks:

Together with process experts define demands on new equipment and rooms.


Prove that ordered equipment and rooms meet said demands.


Risk assessments and change control.


Validation deviation handling


Tasks depending on individual expertise.


The nature of the position is both administrative and hands-on with equipment. A calm, technical and focused approach to scientific work is critical to succeed in this role. You must be able to demonstrate strong written and verbal communication skills and be fluent in English. A minimum of basic Swedish is required. We are small and highly collaborative group, and you are expected to bring a positive force to the team and be prepared to assist where needed.
 


 
 
For further information, please contact:
Peter Boman, Head of Operations, peter.Boman@nxbio.com     
+4670 571 94 63
Akademikerna, Isabel Edström,  isabel.edstrom@nxbio.com                                    
Unionen, Jan Atterhagen, jan.atterhagen@nxbio.com                                                                          
 
 
Send your application via our website, https://www.nxbio.com/careers selection is ongoing
 Then send your application last 2024-09-20