Catalent, Inc. is looking for a Quality Engineer II, Validation to provide quality oversight and ensure compliance with regulations for their Kansas City facility, specifically focusing on Computer System Validation, Equipment Qualification, Cleaning Validation, Process Validation, Metrology, Maintenance, and Facilities.
Requirements
- Review and approval of all Computer System Validation and Equipment Qualification documents
- Review and approval of Cleaning and Process Validation documents
- Quality oversight of Metrology, Maintenance, and Facilities
- Determine validation and qualification requirements for equipment, novel technologies, and newly designed process equipment and processes
- Ensure daily operations, processes, and procedures comply with applicable regulations and Quality Policies
- Develop SOPs that meet all applicable regulatory requirements
- Drive systematic problem solving and process improvement approach using quality engineering tools including Six Sigma, DMAIC, Statistical Process Control, Design of Experiments
Responsibilities
- Provides review and approval of all Computer System Validation and Equipment Qualification documents for the Kansas City PCH-EP Business
- Assists the Associate Director, Quality Assurance in review and approval of Cleaning and Process Validation documents
- Provides quality oversight of Metrology, Maintenance, and Facilities at the site
- 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
- Review and ensure all process, material, and material changes are engineering sound and in compliance with all FDA QSR/cGMP, ISO, and Quality Policies of the company
Other
- BS or BA in a Scientific or Engineering Discipline
- 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
- Good organizational skills relating to management of associates’ daily activities
