Process Engineer - Fill Finish

  • location: Bradley, IL
  • type: Permanent
  • salary: $65,000 - $85,000 per year
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job description

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.

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.

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