Sr Mfg Systems Engineer
7 days ago
**Sr Mfg Systems Engineer**:
Amgen Singapore Manufacturing
**HOW MIGHT YOU DEFY IMAGINATION?**
Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Sr Mfg Systems Engineer **in **Amgen Singapore Manufacturing.**
**Sr Mfg Systems Engineer**:
**Live**:
**What you will do**
As a Sr Mfg Systems Engineer, you will be responsible to provide engineering domain expertise support to the manufacturing plants, utilities and site facilities operation to ensure consistent product supply and deliver production target. You will be entrusted with the responsibility to ensure maximum plant capabilities through continuous improvement initiatives and projects working with group of multi-functional experts. You are the hands-on leader actively involved in project delivery and provide the overall direction for the technical design, utilization and expansion of the automation control so that equipment and facilities will be optimized in accordance to Good Manufacturing Practice, Good Engineering Practice and in compliance with regulatory requirements as well as EHSS requirements.
**Responsibilities**:
- Lead and run the development of new product launch, new capabilities and optimization operational project initiatives to facilitate technical transfer of new program into manufacturing and provide the automation solution
- Provides technical support for new equipment/process start-ups and operation
- Responsible for the execution of all design, build and run activities
- Ensure robust testing of new configuration features based on structure risk assessments
- Coordinate validation activities in collaboration with Manufacturing, IT, and QA
- Partner with multi-functional teams to ensure end-to-end process design and system integration to improve operational efficiency
- Find opportunities to improve existing control processes and equipment by demonstrating and setting industry best practices
- Lead complex operational plant solving efforts and investigation of production process, equipment, systems and code/configuration
- Perform Root Cause Analysis, develop corrective and preventive actions, effective countermeasures and implement the solutions to prevent recurrence
- Work closely with stakeholder to ensure production supply
- Collaborate with multi-functional team to resolve incidents, events or deviations
- Provide operational support to the GMP processes including some off-hours on-call support
- Support plant improvement initiatives and projects
- Active involvement in proposing the direction and implementation of the automation control
- Make changes to manufacturing process control under strict GMP change control management process to optimize processes and maintain compliance
- Update or develop standard operating procedures, work instructions, functional / design specifications associated with automation control and system
- Support engineering process performance management, audit and inspection
- Provide technical guidance to team of engineers
- Provide training to plant personnel on automation control process
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
- Promote Safety, Quality and Compliance culture and continuous improvement mentality that lead to plant safety, quality and compliance to regulatory requirement
- Support Service Owner and System Owner roles for DeltaV, PLCs, and other site Automation systems at ASM
**Win**:
**What we expect of you**:
**Qualifications**:
- Doctorate Degree in Engineering, Information Systems, Computer Science, or Life Sciences OR
- Master Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 2 years of directly related experience OR
- Bachelor’s Degree in Engineering, Information Systems, Computer Science, or Life Sciences and 4 years of directly related experience OR
- High School Diploma in Engineering, Information Systems, Computer Science, or Life Sciences / GED and 8 years of directly related experience
- Preferred 6+ years’ experience in manufacturing automation, particularly in biotechnology or pharmaceutical industries
- Hands on experience with automation systems and be particularly proficient in Emerson and Siemens technology
- Demonstrated ability to lead and run projects and work effectively as a teammate
- Solid understanding of pharmaceutical/biotech processes
- Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards
- Solid understanding of EHSS requirements
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