Holly Springs, North Carolina, United States · On-site
$149k–$201k/yr
Career CategoryEngineeringJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with seriou…
Skills: Process Engineering, Downstream Purification, People Management, Commissioning & Qualification, cGMP
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob Description Amgen is searching for a Associate Endpoint Security Engineer who will report to the Manager, Endpoint Security. This position will provide essential services that enable…
Skills: Endpoint Security, MDM, Intune, Workspace One, JAMF
Breda, North Brabant, Netherlands · Hybrid
Career CategoryEngineeringJob Description At Amgen, our mission is simple: to serve patients. Every day, our teams ensure that critical manufacturing processes run safely, reliably, and compliantly — enabling the deliver…
Skills: Maintenance Engineering, HVAC, Refrigeration, Compressed Air, Chilled Water
Breda, North Brabant, Netherlands · Hybrid
Career CategoryEngineeringJob Description At Amgen, our mission is simple: to serve patients. Every day, our teams ensure that critical manufacturing processes run safely, reliably, and compliantly — enabling the deliver…
Skills: Mechanical Engineering, HVAC, Chilled Water Systems, Boilers, Compressed Air
Breda, North Brabant, Netherlands · Hybrid
Career CategoryEngineeringJob Description At Amgen, our mission is simple: to serve patients. Every day, our teams ensure that critical manufacturing processes run safely, reliably, and compliantly — enabling the deliver…
Skills: Preventive Maintenance, Corrective Maintenance, Predictive Maintenance, HVAC, Refrigeration
Breda, North Brabant, Netherlands · On-site
Career CategoryManufacturingJob Description At Amgen, our mission is simple: to serve patients. Every day, our teams ensure that life-changing medicines are manufactured, packaged, and delivered safely and reliably to pa…
Skills: Automated Production Lines, GMP Compliance, Technical Troubleshooting, SAP, Manufacturing Execution Systems (MES)
Hyderabad, Telangana, India · On-site
Career CategoryClinical DevelopmentJob Description Senior Manager, Database Design Role Name: Senior Manager, Database Design Department Name: Data Management Role GCF: Level 6A ABOUT AMGEN Amgen harnesses the best of bi…
Skills: Database Design, Clinical Data Management, People Leadership, Vault CDMS, Medidata Rave
Hyderabad, Telangana, India · On-site
Career CategoryEngineeringJob DescriptionAbout the Role Amgen is seeking a Senior Associate specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE). In this role, you wi…
Skills: Commissioning & Qualification, Technical Writing, GMP Documentation, Risk Assessment, Validation Protocols
Hyderabad, Telangana, India · On-site
Career CategoryClinical DevelopmentJob Description Associate Director, Database Design Role Name: Associate Director, Database Design Department Name: Data Management Role GCF: Level 6B ABOUT AMGEN Amgen harnesses the be…
Skills: Database Design Strategy, Clinical Data Management, People Management, Governance Frameworks, Digital Transformation
Hyderabad, Telangana, India · On-site
Career CategoryEngineeringJob DescriptionAbout the Role Amgen is seeking a Senior Associate specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE). In this role, you wi…
Skills: Commissioning & Qualification, Technical Writing, GMP Documentation, Risk Assessment, Validation
Shanghai, Shanghai, China · Hybrid
Career CategoryProject ManagementJob DescriptionWhat You Will Do The Strategic Projects & Operations Excellence (SPO) Lead is a key member of the China Leadership Committee (CLC) and reports directly to the China General…
Skills: Strategic Planning, Commercial Excellence, Operations Excellence, Project Management, Marketing Excellence
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living wit…
Skills: MuleSoft Anypoint Platform, Databricks, Python, PySpark, API Design
Hyderabad, Telangana, India · On-site
Career CategoryEngineeringJob DescriptionAbout the Role Amgen is seeking a Senior Associate specializing in Commissioning & Qualification (C&Q) to join the Engineering C&Q Center of Excellence (CoE). In this role, you wi…
Skills: Commissioning & Qualification, Technical Writing, GMP Documentation, Risk Assessment, Validation Protocols
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob Description In this vital role you will serve as the Sourcing Manager for G&A AND GCO Cross Category. Reporting to the Amgen India Direct Lead, you will support the sourcing strategy…
Skills: Strategic Sourcing, Supplier Negotiation, Contract Management, Data Analytics, SAP Ariba
Hyderabad, Telangana, India · On-site
Career CategoryOperationsJob Description Role: Senior Manager, Commercial Data Management ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives eas…
Skills: Data Management, Team Leadership, Stakeholder Management, AWS, Databricks
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob DescriptionJoin Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with…
Skills: SQL, Python, R, AWS, Databricks
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob Description At AMGEN, Technology isn’t just a support function—it’s a catalyst for discovery, transformation, and real-world impact. Here, your ideas fuel innovation that improves an…
Skills: Endpoint Security, MDM Systems, Windows OS, MacOS, iOS
Hyderabad, Telangana, India · On-site
Career CategorySales & Marketing OperationsJob Description Commercial Analytics Manager Amgen India (AIN) The Commercial Analytics team at Amgen plays a pivotal role as a strategic partner to Commercial leadership, deliv…
Skills: SQL, Excel, Python, Tableau, AWS
Hyderabad, Telangana, India · On-site
Career CategoryInformation SystemsJob Description ABOUT AMGEN 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 discover, dev…
Skills: Requirements Gathering, SQL, SAFe Framework, Agile, Scrum
Thousand Oaks, California, United States · Hybrid
$199k–$269k/yr
Career CategorySales & Marketing OperationsJob Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients l…
Skills: Data Governance, Vendor Management, Contracting Coordination, Commercial Data Operations, Data Strategy
Holly Springs, North Carolina, United States • On-site
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Oversee the engineering team and lead technical projects to optimize drug substance manufacturing processes and product design. Ensure the reliability of 24/7 plant operations while managing the commissioning and qualification of process equipment.
Requires a degree in engineering with significant experience (up to 12 years depending on degree level) and at least 2 years of people management experience. Preferred candidates have a background in biopharmaceutical downstream purification and experience in regulated cGMP environments.
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Manager Process Engineering Downstream
What you will do
Let’s do this! Let’s change the world! In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems, optimize processes, and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.
The Senior Manager Process Engineering will join the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director , partnering closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start-up, focusing on Process engineering and plant equipment as well as hiring and training the staff required to support startup and operations.
Key responsibilities include:
Site design, construction, start-up, and operational readiness:
Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery.
Ensure systems are installed, operating safely, and comply with pertinent environmental health/safety practice, rules and regulations.
Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.
Site Operations:
Provide system ownership for process equipment typically used in biologics manufacturing, including Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
Lead a team of Process Engineering professionals and serve as the main point of contact for Process and equipment engineering function.
Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.
Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
Work with original equipment manufacturers for breakdown and planned maintenance of process equipment.
Work with integrated service providers for day-to-day operational activities, breakdown and planned maintenance.
Lead identifying and implementing engineering-based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
Provide system guidance to identify performance risks and implement risk reduction strategies.
Provide technical support to troubleshoot, identify and resolve process and system issues as needed.
Provide strategic, tactical management, and leadership to ensure 24x7 day-to-day reliability of plant operations.
Participate in the budgeting process for process engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
10% domestic/international travel
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The collaborative individual we seek is a leader with these qualifications:
Basic Qualifications
High school diploma / GED and 12 years of engineering experience OR
Associate’s degree and 10 years of engineering experience OR
Bachelor’s degree and 8 years of engineering experience OR
Master’s degree and 6 years of engineering experience OR
Doctorate degree and 2 years of engineering experience
And
In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications
Bachelor’ s degree in Chemical or Mechanical Engineering or related technical field.
8+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment focused on process and plant engineering function.
Demonstrated people management/leadership experience.
Direct knowledge of biopharmaceutical production facility with direct experience with Downstream Purification (e.g. Chromatography and viral Filtration skids, UFDF), and CIP/SIP Skids.
Experience with Tech Transfer, Process Design, and Commissioning & Qualification.
Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.), experience interacting with regulatory agencies and inspectors, and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
Independent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork
Strong leadership, technical writing, and communication/presentation skills
Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
#WeareBiotech
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
#WeareBiotech
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
