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Quality Engineer II, Validation
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Catalent Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. Catalent Pharma Solutions in Kansas City, MO is hiring a
Quality Engineer II, Validation . The Quality Engineer II, Validation provides review and approval of all Computer System Validation and Equipment Qualification documents for the Kansas City PCH-EP Business, and assists the Associate Director, Quality Assurance in review and approval of Cleaning and Process Validation documents. The Role
Work closely with manufacturing, engineering, development, analytics, QC, and technical support to ensure high quality processes are developed and deployed. Work with operations, engineering, quality, and validation teams to determine validation and qualification requirements for equipment, novel technologies, and newly designed process equipment and processes. Work closely with metrology, equipment maintenance, and facilities maintenance to ensure daily operations, processes, and procedures comply with applicable regulations and Quality Policies. Drive systematic problem solving and process improvement approach using quality engineering tools including Six Sigma, DMAIC, Statistical Process Control, Design of Experiments. The Candidate
Education or Equivalent: BS or BA in a Scientific or Engineering Discipline Experience: 12+ years of Scientific or Quality Assurance/Quality Control or Validation Experience Clear understanding of related SOPs, cGMPs and as necessary to accomplish daily tasks; Communicates clearly with internal and external clients, both verbal and written Why you should join Catalent:
Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to DisabilityAccommodations@catalent.com.
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Quality Engineer II, Validation
role at
Catalent Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. Catalent Pharma Solutions in Kansas City, MO is hiring a
Quality Engineer II, Validation . The Quality Engineer II, Validation provides review and approval of all Computer System Validation and Equipment Qualification documents for the Kansas City PCH-EP Business, and assists the Associate Director, Quality Assurance in review and approval of Cleaning and Process Validation documents. The Role
Work closely with manufacturing, engineering, development, analytics, QC, and technical support to ensure high quality processes are developed and deployed. Work with operations, engineering, quality, and validation teams to determine validation and qualification requirements for equipment, novel technologies, and newly designed process equipment and processes. Work closely with metrology, equipment maintenance, and facilities maintenance to ensure daily operations, processes, and procedures comply with applicable regulations and Quality Policies. Drive systematic problem solving and process improvement approach using quality engineering tools including Six Sigma, DMAIC, Statistical Process Control, Design of Experiments. The Candidate
Education or Equivalent: BS or BA in a Scientific or Engineering Discipline Experience: 12+ years of Scientific or Quality Assurance/Quality Control or Validation Experience Clear understanding of related SOPs, cGMPs and as necessary to accomplish daily tasks; Communicates clearly with internal and external clients, both verbal and written Why you should join Catalent:
Defined career path and annual performance review and feedback process Diverse, inclusive culture Positive working environment focusing on continually improving processes to remain innovative Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to DisabilityAccommodations@catalent.com.
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