Process Engineer - Fill Finish
Randstad is seeking a Process Development Engineer - Fill Finish for our client, a biotechnology production facility in Bradley, IL. The person in this role will initially be a key player in an expansion project of the production facility and act as a technical representative of manufacturing during the project. This is a fantastic opportunity to get in on the ground floor of this exciting project!
* Provide technical support relative to the Fill-Finish manufacturing process 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 and analyze trend reports on production processes and track effectiveness of changes. Communicate this information to department personnel and site management on a routine basis.
* Coordinate document changes.
* Analyze quality indicators, including yields, microbial data, environmental monitoring, deviations, etc.
* Evaluate information related to process conditions and assesses their state of control.
Working hours: 7:00 AM - 4:00 PM
* Excellent computer skills and willingness to learn new programs.
* Effective communication and team-building skills.
* Able to communicate professionally with people at all levels of the organization.
* Prior experience or involvement in a large-scale project from start to finish.
* Ability to work in a dynamic environment and be comfortable working with occasional ambiguity.
* Open to occasional travel.
* BA/BS in a scientific or technical discipline preferred (microbiology, biology, chemistry engineering, mechanical engineering, electrical engineering).
* 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.
* Pharmaceutical or biotechnology industry experience is preferred.
* Experience with aseptic filling or packaging is strongly preferred.
* Thorough knowledge of statistical process control principles and applications.
* Solid understanding of cGMP guidelines.
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