Randstad is seeking Process Scientist-Bulk for a biotechnology facility in Bradley, Illinois. The person in this role will lead or provide technical support relative to bulk manufacturing for departmental projects, change controls, risk assessments, deviations, CAPAs and audits; drive and/or coordinate process improvements, utilizing the change control system as required; and generate and analyze trend reports on production processes (both in-process and FIN) and track effectiveness of changes, while supporting a strong cGMP environment.
--Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPA's and audits.
--Provide data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Micro, Engineering and Validation.
--Utilize project management skills to track progress of projects to ensure milestones are met
--Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharma companies.
--Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set.
--Generate an analyze trend reports on production processes and track effectiveness of changes. Communicate this information to department personnel and site management on a routine basis.
--Coordinates document changes utilizing DCMS
--Analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc. Evaluates information related to process conditions and assesses their state of control.
Working hours: 7:00 AM - 3:30 PM
--Excellent computer skills and willingness to learn new programs.
--Effective communication and team-building skills are necessary to successfully participate on project teams.
--BA/BS in a scientific or technical discipline preferred. Strong academic analytical/statistical mathematical background desired.
--With a BS/BA in scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or lab environment
--With a BS/BA in another discipline, 5+ years in a professional role within a pharma manufacturing environment.
--Thorough knowledge of statistical process control principles and applications.
--Solid understanding of a cGMP guidelines.
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