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Specialist IS Bus System Analyst

4 months ago

Holly Springs, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

IS Business Systems AnalystLive

What you will do

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 disposable 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.

Lets do this. Lets change the world. In this vital role you will join our ANC DTI (Digital Technology & Innovation) team to help drive productivity through the company by creating opportunities to stop, optimize processes and then implement and automate as appropriate.

Responsibilities:

Foster collaboration with business and DTI partners to drive the adoption and support of automated systems and platforms, aligning with strategic business goals.

Conduct thorough systems analysis and requirements gathering, propose system solutions to meet business needs, and lead the implementation and post-implementation support.

Attain an expert-level comprehension of automation, business, and analytical platforms, focusing on detailed 'As Is' and 'To Be' process mapping, and identifying functional gaps between business and DTI.

Champion computerized system compliance initiatives, managing change and release processes to ensure adherence to corporate, GxP, and SOX compliance standards on all platforms.

Lead computer validation testing efforts, overseeing projects and resources, analyzing test outcomes, and preparing executive summaries.

Actively engage with key vendors and platform owners to understand capabilities and leverage platforms for addressing compliance and business challenges.

Develop and maintain comprehensive policies, standards, and user guides to ensure consistent application across platforms.

Provide robust support for the release management and engagement of all team platforms.

Ensure strict adherence to Amgens regulatory standards and procedures for all computerized systems.

Offer expert guidance and establish standards for high-quality documentation, acting as the intermediary between DTI and Quality functions.

Actively contribute to the data integrity initiatives for automation, business, infrastructure, and analytical platforms.

Provide DTI compliance support to maintain automation, business, and analytical platforms in a validated, compliant state, ready for inspections.

Work in collaboration with DTI system and business owners to identify and implement compliant solutions for systems.

Engage in all phases of the Computerized Systems Lifecycle, from documenting business client expectations and requirements to analyzing processes and systems, and articulating solutions for cross-system integration.

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 have these qualifications.Basic Qualifications:

Doctorate degree Or

Masters degree and 3 years of Information Systems experience, Or

Bachelors degree and 5 years of Information Systems experience, Or

Associate degree and 10 years of Information Systems experience, Or

High school diploma / GED and 12 years of Information Systems experiencePreferred Qualifications:

Designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem and custom software developed platforms.

Cultivate a strong customer service, building and sustaining effective relationships across all organizational levels. Demonstrate exceptional collaboration skills, confidently address action points with stakeholders, and excel in both verbal and written communication.

Strong verbal and presentation skills, capable of engaging diverse audiences, including both technical and non-technical stakeholders.

Experienced in writing and publishing internal white papers, user documentation, and SOPs, ensuring clarity and accessibility.

Solid experience in Data Integrity, applying principles to Business, Automation, and Analytical Systems, coupled with expertise in Validation Lifecycle Management.

Extensive experience in computer systems validation and navigating regulatory environments including Computer Validation Lifecycle Management expertise.

Hands-on experience in liaising with regulatory agencies, contributing to regulatory inspections, and overseeing audits.

Domain knowledge of health care/life sciences would be a plus.

Continuous improvement knowledge

Experience with SAFe and traditional Agile methodology coupled with strong GxP experience and knowledge on regulations FDA Title 21 CFR Part 210 and 211.

Experience with several Industry 4.0 technologies is a plus

Knowledge on methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping)

Data analysis and reporting experience by using analytics, visualization, and database technologies (OSISoft PI, Power BI, Spotfire, Tableau)

Full stack development including infrastructure cloud services (Storage, VMs, Network, etc.) as well as application and user experience.

Industry experience with software development of key manufacturing systems and applications that support manufacturing, preferably biotechnology, pharmaceutical, or related industry.

Data analysis and reporting experience by using analytics, visualization, and database technologies (OSISoft PI RtReports, Spotfire, Tableau)

Hands-on experience with computerized systems including troubleshooting, reliability, and performance improvements.

Expertise with translating business requirements/user stories to technical requirements and recommend solutions for automation.

Experience in supporting key manufacturing systems with 24x7 operations individually and with vendors.

Experience or solid grasp of current Good Manufacturing Practices (GMP), 21CFR Part 11 regulations, change control, validation.

Experience with Agile Product Development delivery and SAFe practices.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.

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.

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 possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.com

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.

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 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.