Job Description:
HOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
VALIDATION ENGINEER
LIVE
WHAT YOU WILL DO
Let’s do this. Let’s change the world. Amgen’s Attribute Sciences (AS) department within the Process Development (PD) organization defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development. Be part of Amgen's Pre-Pivotal organization where you will support compliance, safety, lab operations, and training. As part of the Operations team, you will work closely with AS scientists, Information Systems (IS), and Quality Assurance (QA) to ensure the readiness of critical lab equipment.
- Lead and/or support a varied portfolio of IS projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
- Lead selected efforts to craft, build, and develop rapid Proof-of-Concept (POC) automated solutions and services. Quickly prove or disprove the concepts being considered.
- Ensuring consistency to data integrity standards and procedures for computer-related systems in qualifying and maintaining analytical laboratory instruments.
- Synthesize requirements from end-users, application software, and cybersecurity experts to develop the best automation solutions for computerized equipment.
- Participate in system design, preparation of test protocols, analysis of test results, requirement traceability matrixes, and preparation of summaries.
- Perform gap assessments and define resolutions in compliance with cGMP requirements.
- Work closely with other business and IS Process Engineers to find opportunities to stop inefficient practices and codify them into automated solutions and platforms.
- Ability to quickly assimilate knowledge of new platforms, languages, tools and technologies.
- Special Projects such as Operating Software Upgrades (ex Win10), Software Platform Upgrades (ex: Empower), etc.
- Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
WIN
WHAT WE EXPECT OF YOU
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.
BASIC QUALIFICATIONS:
Master’s degree and 2 years of Information Systems and/or Business Analysis and/or Project Management experience
OR
Bachelor’s degree and 4 years of Information Systems and/or Business Analysis and/or Project Management experience
PREFERRED QUALIFICATIONS:
- BS or MS in computer science, engineering, information systems, or related field
- Industry experience with software development of augmented reality solutions and digital
- Methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping)
- Distributed Control Systems (DCS) and Supervisory Control or Data Acquisition (SCADA) applications that support manufacturing, preferably biotechnology, pharmaceutical, or related industry.
- Development of infrastructure cloud services (Storage, VMs, Network, etc.) as well as application and user experience.
- Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements.
- Expertise in translating business requirements to technical requirements and recommending solutions for automation.
THRIVE
WHAT YOU CAN EXPECT OF US
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
This position will be paid on an hourly basis. The annualized base pay range for this opportunity in the U.S. is $41.47 to $54.12.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:
- 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 and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
