Sr Associate Manufacturing-MES
Singapore – Singapore
The Senior Associate Manufacturing (MES) will be responsible for development, configuration and testing of Master Batch Records (MBRs) from initial to final design. The successful candidate will have three to five years of experience in a pharmaceutical or biotech industry and will have demonstrated competency in leading teams to deliver MBR designs in time with project timelines.
The ideal candidate will have:
- Broad technical experience in MES systems.
- Experience of working in bulk manufacturing operations or have a demonstrated capacity to learn quickly and adapt to new technology.
- The ability to adapt quickly to the demands of commercial manufacturing operations.
MES Technical Expertise
- Responsible for the development, configuration and testing of Master Batch Records (MBRs) from initial to final design.
- Responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions.
- Responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.
- Responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).
- Responsible for any applicable equipment integration design, configuration and testing to allow MBR interaction with shop floor equipment – OSI PI, Recipe Managers – DeltaV
- Responsible for resolving interface errors and stock discrepancies between ERP/MES as required.
- Responsible for providing technical support where required and as directed by Operations leadership
- Other Responsibilities as deemed necessary.
- Accountable for Delivering Results by:
- Communicating issues and promptly escalating issues that may jeopardize manufacturing deliverables.
- Accountable for work which is guided by operational and project objectives and with some supervision
- Manage multiple assignments and processes
- Develop solutions that are thorough, practical and consistent with functional objectives
- Partners and communicates effectively with other departments and support functions to ensure positive working relationships.
- Assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
- Accountable for the safe operation of the area ensuring all safety policies are adhered to and that any incidents are reported in a timely manner. Promotes a positive safety culture
Knowledge and Problem Solving
- Broad knowledge within own specialty area
- Understands the core business process and purpose of the functional area in Amgen’s commercialization process
- Handles diverse scope of issues that require evaluation of a variety of factors.
- Implement, assign, lead or participate in projects
- Applies analytical skills to evaluate and interpret situations / problems using multiple sources of information
- Anticipates and prevents potential problems
Basic Qualifications & Relevant Experience preferred:
- Master’s degree in Engineering or Science
- Bachelor’s degree in Engineering or Science and 3 years of Manufacturing experience
- Associate’s degree in Engineering or Science and 5 years of Manufacturing experience
- Working knowledge of manufacturing in pharmaceutical/biotech industries
- Knowledge of regulation requirements (GMP & EH&S)
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites, social media chat and/or unsolicited emails. These scams seek to obtain personal information or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application or send checks to be deposited in bank accounts. When in doubt, please check to see if the position in question is posted on the Amgen career site. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov and thank you for your assistance.