PHARMACEUTICAL PROCESS DEVELOPMENT ENGINEER AND SOURCE MATERIAL

Our client is a world leader in the research, development and manufacture of vaccines and immunotherapy. Their success requires the addition of a Process Development Engineer/Source Material Development Manager to their staff in Eastern Washington. The increasing demands for their products require developing processes to increase production by more than an order of magnitude. The right candidate will have significant experience with all the necessary engineering efforts needed for the manufacture of active biological powder source materials and how to up-scale these processes.

Our client offers a fast paced environment with a growing global biological company that has a small company atmosphere, interesting work with significant responsibilities, impact on the bottom line, international travel, competitive salary and excellent benefits.

Duties and Responsibilities:
Process development activities:
Design and optimize scalable processes for manufacturing allergen biological source materials like pollensTest process equipment and determine critical process parameters relevant for design of equipment and scale-up- e.g. lab scale to Pilot and/or Production Scale.Design, plan, complete, analyze, interpret and report experimentsDesign, optimize, new process equipment requirement;author user requirement specifications (in close corporation with Production Unit and/or Director of Engineering),Select appropriate material of construction to meet the process requirementsReview functional description, PFDs and P&IdsPlan and report process validation studiesProcess equipment qualification (review level, typically contracted out)Technology transfer to production unit (protocols, SOPs, training etc.) in cooperation with production unit
Project activities:
prepare time and activity plans (e.g. Gantt Charts) for source material Process Development activities in sync with the overall schedule for the source material production facility project and follow up and report on these activitiesprepare process development budget and resource forecast and follow-up?Coordinate Process Development activities with other discipline engineers such as Mech, Elect, Instrumentation/Controls, Project Manager(s), etc
Please contact by email and submit all resumes in a MS Word format.

We appreciate your interest, however, only those candidates who best meet our requirements will be contacted.
REQUIREMENTS
Bachelor’s degree in chemical or mechanical engineering with at least 5-10 years experience in industrial pharmaceutical development and manufacturingKnowledge of chemical engineering, cGMPs, and pharmaceutical process engineeringAbility to conceptualize, design, develop, build, and optimize pharmaceutical processesKnowledge of Piping and Instrumentation for Chemical/Pharmaceutical ProcessesExperience with chemical process technology and unit operationsKnowledge of Materials of Construction for Chemical/Pharmaceutical ProcessesExperience with powder handling technologies (drying, mixing etc.), contained transfer of fine solids, active pharmaceutical ingredients etc. Experience with up-scaling processes from bench/pilot to production scale, including but not limited to process equipment selection & sizingHands-on practical experience with development and optimization of processes for manufacturing biologicals or pharmaceuticalsKnowledge of cGMP as applied to Product Development Labs and Manufacturing FacilitiesAbility to work independently and systematicallyAbility to travel internationallyMotivated self starterDemonstrate initiative and good interpersonal skillsAbility to work with allergenic materialsGood communication skills; oral, written and presentation