What you will do
This role is within the manufacturing organization of Amgen Singapore Manufacturing. The Associate Manufacturing provides technical support to the manufacturing execution team. We offer a broad exposure to all key aspect of GMP manufacturing as well as tactical and strategic teamwork within the extended manufacturing network.
- Applying engineering principles to recommend, design, and implement new equipment or system modifications
- Working closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to implement operational improvements
- Providing technical support to commercial manufacturing as needed
- Support troubleshooting and resolve equipment, automation, or process issues of simple/moderate complexity in the field
- Ensuring optimal and cost-effective performance and reliability for process systems
- Developing, organizing, analyzing, and presenting results for operational issues and engineering projects of moderate scope and complexity
- Communicating proactively with supervisor and support staff, highlighting issues and proposing solutions
- Technical expert who helps introduce advanced technologies and approaches generally described as "Next Generation Manufacturing" - into the plant.
- Lead and drive root cause analysis investigations arising from major deviations including the development and implementation of corrective and preventive actions
- Initiate and manage change controls of moderate to complex scope including but not limited to continuous improvement and productivity initiatives
- Manage the implementation, development and changes associated with process equipment Commissioning, Qualification and validation
- Prepare, coordinate, and present complex information at cross-functional team meetings, teleconferences, and management reviews
- Provide on-call support
What we expect of you
- Master's degree OR
- Bachelor's degree and 2 years of directly related experience OR
- Associate's degree and/or 6 years of directly related experience OR
- High school diploma / GED and 8 years of directly related experience
- 5+ years' experience in GMP technical support/engineering or manufacturing support environment with at least 3 years' experience in the Pharmaceutical or Biotechnology industries.
- Extensive knowledge of Mammalian Cell Culture, Protein Purification, Single Use Systems
- Experience with Technology Transfer, Process Design, and Commissioning
- Experience with validation and change control methodology
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
- Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.
- Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
- Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
- Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
- Experience that includes the management of complex projects, tasks or processes, or management of functional or cross-functional teams
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, quality engineering, quality control, and quality assurance.
- Experience that has provided the candidate with a detailed understanding of the regulatory and compliance environment, the GMP processes and the business processes associated with typical biotechnology / pharmaceutical manufacturing operations
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Your selection for this role will, may be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.