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PROCESSING APPLICATION
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Job Requirements of Process Engineer III:
-
Employment Type:
Contractor
-
Location:
St. Louis, MO (Onsite)
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Process Engineer III
Careers Integrated Resources Inc
St. Louis, MO (Onsite)
Contractor
Please note location: St. Louis, MO
DEPARTMENT DESCRIPTIONS
The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture based DS Processes within Client biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.
Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.
KEY RESPONSIBILITIES
The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group support commercial operations across a diverse network of manufacturing facilities and external partners. Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
Reviews manufacturing processes, deviations, and/or development and production data.
Reviews manufacturing batch records, protocols, and control strategies.
Provide technical support and data analysis for investigations and deviation resolution.
Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
Bachelor s degree in engineering or science with 5 years of experience
OR
Master s degree in engineering or science with 3 years of experience
Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
LEADERSHIP QUALIFICATIONS
N/A
PREFERRED QUALIFICATIONS
Experience with Good Manufacturing Practices and supporting a commercial facility
Experience in cell culture and/or downstream purification (direct lab experience a plus)
Experience with equipment qualification and process validation
Familiarity with formal root cause analysis and/or risk assessment
Experience working with statistical analysis software and investigative data analysis
Experience with project leadership
Experience communicating with cross functional teams
Strong technical writing and communication skills
Proficient in Microsoft Word, Excel, and PowerPoint
SPECIAL WORKING CONDITIONS
Ability to gown and Product entry to manufacturing areas
Ability to travel (up to 20% of time)
DEPARTMENT DESCRIPTIONS
The Recombinant Mammalian DS Platform function within global MSAT is the owner of Life Cycle Management of mammalian cell culture based DS Processes within Client biologics manufacturing network. We deliver innovative, robust, and cost-effective next generation processes, enable launch of new products, and provide commercial manufacturing support. The function is responsible for tech transfer activities including process fit-gap assessment, process validation, prepare dossier sections, & PAI support to enable launch of new and LCM products.
Our expansive portfolio covers 17 products, 5 modalities, 3 expression systems within 12 internal and external global sites in US and EU. We will be supporting launch of 20 new products in the next 5 years including monoclonal and multi-specific antibodies, fusion proteins, antibody-drug conjugates. In recent years we have successfully established second-generation manufacturing process with continuous process platform. We are pursuing future innovations such as digital labs, factory of future and advanced analytics-based process understanding and control.
KEY RESPONSIBILITIES
The successful candidate will work with a group of scientists and engineers responsible for support of commercial mammalian cell culture processes in the external manufacturing MSAT group. This group support commercial operations across a diverse network of manufacturing facilities and external partners. Key responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
Reviews manufacturing processes, deviations, and/or development and production data.
Reviews manufacturing batch records, protocols, and control strategies.
Provide technical support and data analysis for investigations and deviation resolution.
Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
Bachelor s degree in engineering or science with 5 years of experience
OR
Master s degree in engineering or science with 3 years of experience
Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
LEADERSHIP QUALIFICATIONS
N/A
PREFERRED QUALIFICATIONS
Experience with Good Manufacturing Practices and supporting a commercial facility
Experience in cell culture and/or downstream purification (direct lab experience a plus)
Experience with equipment qualification and process validation
Familiarity with formal root cause analysis and/or risk assessment
Experience working with statistical analysis software and investigative data analysis
Experience with project leadership
Experience communicating with cross functional teams
Strong technical writing and communication skills
Proficient in Microsoft Word, Excel, and PowerPoint
SPECIAL WORKING CONDITIONS
Ability to gown and Product entry to manufacturing areas
Ability to travel (up to 20% of time)
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