Process Scientst, API Manufacturing

CSL Behring Kankakee , IL 60901

Posted 4 months ago

Lead or provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Drive and/or coordinate process improvements, utilizing the change control system as required. Generate and analyze trend reports on production processes (both in-process and FIN) and track effectiveness of changes. Support a strong cGMP environment.
1 Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPA's and audits.
2 Provide data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation.
3 Utilize project management skills to track progress of projects to ensure milestones are met.
4 Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies.
5 Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set.

Official Reference Copy

McIntyre, Luke D Approved: 15-Dec-2011 5.0
08-May-2019 10:45:10K3_GDRS_01
2

Main Responsibilities and Accountabilities (continued)
6

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.
7 Coordinates document changes utilizing DCMS.
8


Analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control. Position Qualifications and Experience

Requirements:

Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position. Education BA/BS in a scientific or technical discipline preferred. Strong academic analytical/statistical mathematical background desired.

Experience

With a BS/BA in a scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or laboratory environment.

With a BS/BA in another discipline, 5+ years in a professional role within a pharmaceutical manufacturing environment.

Competencies Thorough knowledge of Statistical Process Control principles and applications. Solid understanding of cGMP guidelines.

Excellent computer skills and willingness to learn new programs. Effective communication and team-building skills necessary to successfully participate on project teams

Worker Type:

Employee

Worker Sub Type:

Regular



icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Scientist Process Manufacturing

CSL Behring

Posted 1 week ago

VIEW JOBS 8/14/2019 12:00:00 AM 2019-11-12T00:00 Lead or provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Drive and/or coordinate process improvements, utilizing the change control system as required. Generate and analyze trend reports on production processes and track effectiveness of changes. Support a strong cGMP environment. 1. Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPA's and audits. 2.Analyzes quality indicators, including yields, microbial data, environmental monitoring, deviations, etc., evaluates information relating to process conditions and assesses their state of control. 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. 3. Utilize project management skills to track progress of projects to ensure milestones are met. 4. Drive process improvements and coordinate document changes (DocNet). Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set. 5. Provide (statistical) data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation. 6. Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies. 7. Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of "non-value added" activities. 8. Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. 9. Complies with requirements from CSL Behring's Safety Program, including Health and Safety mandates and OSHA requirements. 10. Completes any other duties/responsibilities assigned by senior management. Education: BA/BS in a scientific or technical discipline preferred. Strong academic analytical/statistical mathematical background desired. Experience: With a BS/BA in a scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or laboratory environment. With a BS/BA in another discipline, 5+ years in a professional role within a pharmaceutical manufacturing environment. Worker Type: Employee Worker Sub Type: Regular CSL Behring Kankakee IL

Process Scientst, API Manufacturing

CSL Behring