Career Category
Engineering
Job Description

Engineer

What you will do

Let's do this! Let's change the world! Do you want to help shape the future of biopharmaceutical manufacturing? Are you interested in working with a diverse product portfolio of life changing products in a dynamic working environment? Would you like to work with a highly motivated team of process science professionals to positively impact patients' lives? Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.

Advancing science and helping patients - these dual passions are ingrained in our culture. They drive our work, our values, and everything we do at Amgen. For staff around the world, our mission to serve patients and our commitment to science makes Amgen a place where we can make a positive difference in people's lives while pursuing a challenging and fulfilling career. To foster a setting in which all staff may excel, we support a variety of growth opportunities, from training and education to expanding current job responsibilities.

As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance processes across the network, including both the Amgen manufacturing network. The technology transfer responsibilities for this role requires a mostly on-site presence. We provide process engineering and process validation support for human therapeutic products (biological drug substance) in clinical development through commercial production. Our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation. You will work as a member of a team of engineers and scientists, as you use engineering principles to implement manufacturing processes in a cGMP environment. The successful candidate will apply process engineering knowledge in support of technology transfer and clinical and commercial drug substance manufacturing at Amgen's Thousand Oaks site.

Specific Responsibilities include but are not limited to:

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select, and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
• Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
• Transfer processes and perform process improvements from the laboratory into the manufacturing facility and between manufacturing sites
• Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for processes and/or system modifications.
• Continuous improvement mindset; seeks out opportunities to gain efficiencies within business process workstreams
• Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
• Work with consultants, architects, and engineering firms on development of standard design documents.
• Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments
• Support non-standard shift organization and extended hours, as per business needs.
• Provide on-the-floor technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations
• Provide routine process monitoring and troubleshooting
• Provide technical support for process related deviations (NCs), CAPAs and change controls
• Represent process development and interface with other functions such as Manufacturing, Quality, Validation and Regulatory

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a collaborative team player with these qualifications.

Basic Qualifications:

• Master's degree OR
• Bachelor's degree and 2 years of Engineering or Operations experience OR
• Associate's degree and 6 years of Engineering or Operations experience OR
• High school diploma / GED and 8 years of Engineering or Operations experience

Preferred Qualifications:

• Education background in Chemical Engineering, Bioengineering or Biotechnology
• 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical manufacturing processes.
• Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
• Experience working with commercial manufacture of biologics using single use technology
• Basic understanding cGMP requirements of manufacturing at large scale.
• Experience related to upstream and/or downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
• Experience in working with design and optimization of pharmaceutical processing unit operations including cell expansion, harvest, clarification, Protein A, IEX, SEC, TFF, UFDF, and sterile filtration among others for a variety of biological molecules
• Experience in the analysis of data generated from a variety of analytical techniques
• Regulatory knowledge and interactions
• Project management skills
• Strong oral and verbal communication and presentation skills
• Person will have strong capability of scientific/engineering/laboratory analysis, troubleshooting and ability to apply advanced problem solving skills
• Ability to develop and follow detailed protocols
• Independently motivated with ability to multi-task and work in teams

What you can expect of us

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Salary Range
88,281.00USD -119,439.00 USD