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Skills: Contamination Control, GMP Readiness, Deviation Management, CAPA, Change Control
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Full-time
high school, associate degree, bachelor degree, postgraduate degree
Health Insurance, Financial Benefits, Wealth Benefits, Work-life Balance, Career Benefits
Posted 54d ago
~40 hrs/week
Responsibilities
This role supports contamination control, inspection readiness, and process support deliverables for ASM Manufacturing. Key duties include managing deviations, leading investigations, and ensuring GMP compliance through the maintenance of cleanroom procedures and environmental monitoring.
Requirements
Candidates need a degree in a relevant field with corresponding years of experience and technical knowledge of biopharmaceutical processing and cleanroom operations. Proficiency in writing deviations, CAPAs, and change controls, along with a basic understanding of GMP regulatory expectations, is required.
Full job description
Career Category
Manufacturing
Job Description
Senior Manufacturing Associate
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 Senior Manufacturing Associate in Amgen Singapore Manufacturing.
Live
What you will do
This position supports contamination control, inspection readiness and process support deliverables for ASM Manufacturing. Under general direction, the role partners with Manufacturing, Quality, Compliance, Facility & Engineering, EHSS and other stakeholders to maintain GMP readiness, identify potential contamination risks, support investigations and drive assigned improvement actions.
Responsibilities
Contamination Control
Support execution of the ASM1 Manufacturing contamination control program under direction of the Contamination Control Lead.
Own deviations (minor/major), perform data gathering/investigation, impact assessment and documentation support for contamination-related events, deviations and CAPA.
Lead low-to-moderate complexity investigation workstreams and support complex investigations led by the Contamination Control Lead.
Prepare and maintain assigned dashboards, metrics and follow-up trackers for site and network discussions.
Support maintenance of cleanroom procedures, gowning practices, contamination response procedures and environmental monitoring program deliverables.
Coordinate with the EM Sampling team, area owners and cross-functional stakeholders to ensure sampling readiness, timely follow-up and closure of observations.
Drive assigned actions and small-to-moderate improvement initiatives to improve contamination control effectiveness.
Inspection Readiness
Support CAPA applicability assessment and implementation of identified CAPA (if required).
Prepare, verify and organize inspection support materials, storyboards, pressure test packages and evidence binders as assigned.
Support triage room activities during regulatory inspections , including request coordination, document retrieval and response preparation under lead direction.
Partner with Compliance and cross-functional teams to ensure prompt follow-up on inspection requests, observations, near misses and lessons learnt.
Serve as SME to present deviations, CAPA, change control records when required during inspections.
Initiate, assess and implement low-to-moderate complexity change controls with guidance; support complex change controls
Identify digitalization/improvement opportunities to drive improvement in deviation, CAPA and change control work processes
Win
What we expect of you
Basic Qualifications
Masters Degree OR
Bachelor’s Degree and 2 years of directly related experience OR
Associate’s Degree and 6 years of directly related experience OR
High School Diploma / GED and 8 years of directly related experience
Technical knowledge of biopharmaceutical upstream, downstream processing, cleanroom operations and single use systems.
Experience in writing and owning major/minor deviations, CAPA and change controls related to contamination control and/or manufacturing.
Experience leading/supporting investigations, CAPA, audit readiness activities and risk assessments
Basic understanding of GMP and regulatory expectations related to manufacturing documentation, change control, deviations/investigations and CAPA.
Working knowledge of contamination control expectations for biologics manufacturing, including cleanroom behaviour, gowning, EM and contamination response.
Ability to analyse routine EM/process data, identify trends, communicate risks and escalate appropriately
Strong technical writing, communication skills and ability to work effectively with cross-functional stakeholders and network partners.
Ability to work with limited supervision, prioritize assigned deliverables and follow through on commitments.
Practical experience and interest in exploring the use of digital technologies (Power BI, Customized ChatGPT etc) to improve workflows and drive continuous improvement
Your 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.
Thrive
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
Apply now
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.
careers.amgen.com
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.
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Related keywords
BiotechnologyGMPBiopharmaceuticalsUpstream ProcessingDownstream ProcessingCleanroomSingle Use SystemsCAPADeviationChange ControlEnvironmental MonitoringRegulatory InspectionsPower BIChatGPTDigitalizationQuality Compliance
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data 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. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data 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. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical