Process engineer.  Using expertise and knowledge 
of currrent cGMP, process validation programs, 
and analytical technology, the incumbent is 
responsible for regulatory compliance of all 
process validation programs.  

Functions include:  assessing processes for 
their relevance and assesses adequacy of 
engineering equipment; reviewing existing data 
to see if more research and information needs to 
be collated; designs, installs and commissions 
new production units, monitoring modifications 
and upgrades and troubleshooting existing 
processes; applies the principles of mass, 
momentum and heat transfer to process and 
equipment design, including conceptual, scheme 
and detail design; Prepares reports, flow 
diagrams and charts; supports the conversion of 
small scale processes into commercially viable 
large scale operations; assumes responsibility 
for risk assessment, including hazard and 
operability studies for the health and safety of 
all; takes observations and measurements 
directly, as well as collects and interprets 
data from the other technical and operating 
staff involved and works closely with other 
specialists, including:  chemists/analysts 
responsible for the quality control of raw 
materials, intermediates and finished products; 
engineers responsible for plant maintenance; 
commercial colleagues on product specifications 
and production schedules; and the operating 
crew.  

Requires B.S. Chemistry, Chemical Engineering or 
Industrial science. Two years minimum experience 
in validation studies.  Working knowledge of up-
to-date validation.  Must have proficiency in 
computers (Word, Excel) and a working knowledge 
of Good Drug Manufacturing Practices and 
Statistics.