All About pharma vacature

A Biochemical Process Engineer plays a pivotal role In this highly complex and
multidisciplinary environment. Youll develop expertise in the production of raw materials
for medicines with living cells and micro-organisms.
In this position youll e trained !through internal courses and on the "o# to ensure the
highest standards of process integrity and reliaility $ availaility of production e%uipment.
A versatile role in which you perform many tas&s $ responsiilities' process simulation(
functional specification( feasiility studies( reviewing engineering proposals( validation $
%ualification( introduction of new products and)or facilities( facility fit assessments( user
re%uirement specifications( etc.
Its a high level "o on one hand ut real success comes from getting things done. *o the most
important part of this "o is managing multiple pro"ects and leveraging oth internal and)or
external partners.
You have
an +*c. or Ph,. degree in chemical engineering( process engineering or reactor engineering.
You have -. years experience in development of manufacturing processes in the
pharmaceutical industry under /+P. You have experience with P$I,( P0,( ,oE( 1, and
with technology transfer from development to /+P. You have experience in process
validation and wor&ing according to /ood Engineering Practice.
Preferaly you have some years of experience in a managerial position. You have an inspiring
personality and thus &now how to motivate your people.
You are
an enthusiastic( proactive and result oriented team player. You are empathic and possess
excellent coaching and communication s&ills. You also have good analytical aility. You are
enterprising( flexile( accurate( %uality conscious and have good prolem solving s&ills. You
love a dynamic environment and you are good at maintaining timelines while maintaining
%uality
Job Content
+anage and provide technical guidance to third parties on 0inished ,osage !0,#
production and maintenance
2eview of volumes( capacity of the plant( usaility of the e%uipment availale at
3+4s
Estalish control and reporting systems( agreed with third party( including 4peration
5PIs
2eport periodically manufacturing results against estalished 5PIs and o"ectives
3hallenge the various stages of the pro"ect from feasiility to commerciali6ation
Prepare and periodically update the pro"ect plan
2eport periodically and in case of critical deviations
Propose corrective measures throughout the pro"ect
*upport that all production activities are performed according to the existing dossier
and that the necessary data are supplied if variations are introduced.
*upervise the consistency of 3,As and service agreements
7udge when and what external &nowledge should e sourced-in to support production
activities during set up and routine production and manage accordingly
8or& in close cooperation with 2$, function for defining production re%uirements.
Ensure that the values( %uality( and *9E aspects are followed internally and at
partners
Apply the aove points also to controlled 0, production facilities as applicale
Requirements Candidate
Educational level'
Academic degree in Process or +echanical Engineering or Pharmacy or other related
study field.
Advanced degree preferred
5nowledge'
9aving a road( in depth &nowledge !technically)scientifically# with regard to 0,
manufacturing methods and site management
9aving thorough &nowledge of pharmaceutical production activities
Bringing in existing 0, &nowledge( ideally in generics( in order to optimi6e
manufacturing processes and related activities
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