Process Development Engineer

Amgen Singapore ManufacturingHOW 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 Process Development Engineer in Amgen Singapore Manufacturing.LiveResponsibilitiesWhat you will doApplies expertise in the successful coordination of multiple, complex, non-routine activities including tech transfer process qualification, process performance monitoring, floor support, troubleshooting of unit operations.Support/lead complicated investigations, providing concise communications to teams and leadershipCompile and analyze process data using tools such as excel, JMP, SIMCA to inform future decision-making and take predictive actionAuthor technical protocols, technical assessments, and product impact assessmentsVerify data in technical reports, spreadsheets, and regulatory filingsUtilize strong written and verbal communication skills in technical writing and presentationsAll listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodation for additional tasks and responsibilities.WinBasic QualificationsWhat we expect of youMaster’s degree ORBachelor’s degree and 2 years of directly related experience ORAssociate’s degree and/or 4 years of directly related experience ORHigh school diploma / GED and 6 years of directly related experience3+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industriesAt least 2 years’ experience with regulated environments (i.e. cGMP) requiredIn depth cell culture process knowledge, including single-use technologies and harvest technologiesExperience in providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP productionPossess basic understanding of regulatory and cGMP requirementsAble to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvementsAble to escalate relevant issues to project lead and line managementIndependently motivated but also work well in team environmentStrong communication skills (technical writing and verbal communication/presentation)Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approachThriveWhat You Can Expect Of UsAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsYour selection for this role will 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.Apply nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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.