Career Category

Job Description

Role Description

This role will serve as a technical lead/subject matter expert (SME) for both the Biotechnology and Active Pharmaceutical Ingredient (API) facilities in ASM for MES and PI systems. Experience in design, operation, maintenance and improvement of the MES and PI systems will be required to provide advance technical support to both day to day manufacturing and project activities. This role is crucial for Amgen’s success and it will be a key contributor both ASM1 and ASM2 areas.

Responsibilities

General

• Responsible for providing technical support and leading team of Master Batch Record (MBR) designers to provide technical (including on call) support for MES issues during day to day manufacturing activities
• Responsible for supporting/driving continuous improvement initiatives and projects related to MES
• Responsible for leading MES assessment for new product introduction (NPI) site selection and plant fit
• Responsible for leading team of MBR designers to drive timely creation of MBR and e-log books for NPI
• Responsible for the development, configuration and testing of MBR from initial to final design
• Responsible for leading MBR development design reviews including liaising with Manufacturing, Process Development and Quality functions
• Responsible for drafting and reviewing Application Lifecycle test scripts for testing MBR design
• Work with IS/automation to setup up Delta V programs that synchronized with MES
• May be required to own or provide subject matter expertise to SOP, nonconformance, investigations, corrective and preventive actions, change control records or validations

MES Business Owner

• Responsible for timely completion of periodic system access review for MES, PI and Delta V
• Represent ASM as Subject Matter Expert (SME) in global network meetings. Collaborate with corporate team to ensure alignment of local standards/requirements with global procedures
• Responsible for alignment of MBR between ASM and AR30
• Responsible for maintenance of TAP/AV, ensuring adequate number of trainers and personnel to support ASM MES activities
• Perform internal audit and maintain readiness for compliance audit at all time by pro-actively identifying and addressing gaps
• Provide timely feedback to stakeholders and responsible for maintenance of MES related metrics
• Drive/support MES projects including (but not limited to) Global MES standardization project, NPI digital tech transfer, GMBR optimization and system upgrades activities
• Follow up closely with IS system owner for issues impacting MES/PI
• Responsible for management of budget and timesheet of contingent workers and supplier relationship with service providers
• Provide SAP support (when required) in area of material management

Basic Qualifications

• Master’s  degree in Engineering & 4 years of experience in pharmaceutical company or GMP environment OR
• Bachelor’s  degree in Engineering & 6 years of  experience in a pharmaceutical company or GMP environment OR
• Undergraduate diploma in Engineering & 8 years of experience in a pharmaceutical company or GMP environment

Preferred Qualifications/Competencies:

• Good working experience in design, operation, maintenance and improvement of the MES (Werum PAS|X) and PI systems
• General knowledge in Delta V and biopharmaceutical operations/processes such as Media/Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration will be preferred
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation will be preferred
• Familiarity with documentation in a highly regulated environment and ability to interpret and apply GMP
• Demonstrated skills in the following areas:
  • Ability to develop solutions to routine technical problems
  • Technical report writing/presentation
  • Interacts effectively with variety of communication and working styles
  • Dealing with and managing changes
  • Computer Literacy (Trackwise, Delta V, PI)
• Ability to independently determine when additional internal resources are required to solve problems
• Ability to handle multiple projects at the same time with demonstrated skills in the following areas:
  • Schedule development
  • Facilitation
  • Collaboration
  • Basic project management
  • Completion and follow-up
  • Management of contractors and vendors
• Ability to delegate and manage the project work of others with demonstrated skills in the following areas:
  • Project cost development
  • Conflict Resolution
  • Leadership and team building
  • Schedule and resources loading development