17 days old

Specialist Information Systems (IS) Business Analyst - Process Development

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118953649
Amgen

Job ID: R-92399
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Florida - Tampa

Amgen is seeking a hardworking Business Analyst to build leading edge scientific applications with modern technology stacks that will be used by our business partners to drive Amgen's innovation across Operations. The outstanding candidate will join our Product Team to deliver compelling solutions and drive business outcomes aligned with the organization's goals.

The Specialist Information Systems (IS) Business Systems Analyst works within the Operations IS (OIS) group to support the Process Development business organization with a focus on Product Lifecycle Management (PLM) as part of an Operations-wide digital transformation.

The successful candidate will make fundamental improvements in how product information is managed, business processes are digitized/coordinated, and work flow is directed to help Amgen innovate, integrate, and accelerate advancement of Amgen's products.

Role Responsibilities

Primary:
  • Drive solution design as part of the product team, eliciting and capturing requirements, user stories, workflows, and other relevant artifacts to deliver against encouraged business outcomes
  • Review functional and technical designs to identify areas of risk and/or missing requirements
  • Collaborate with the software engineers and architects to ensure all solutions are reliable, maintainable, and well-integrated into existing platforms
  • Develop and execute project plans, identify resource needs, proactively track risks/issues/decisions and understand how to execute IS projects according to time and budget commitments
  • Act as scrum leader - leading backlog grooming, sprint planning, story development, daily scrums, and retrospectives
  • Drive and facilitate all phases of delivery including intake, design, build, testing & validation
  • Assist the product teams in prioritizing work and clearing roadblocks
  • Ensure effective communication between business partners, technical team members and vendors to analyze detailed business requirements and implement solutions
  • Plan and execute on GxP system validation activities including change control, documentation installation qualification (IQ), and operational qualification (OQ)
  • Work with multi-functional representatives within Amgen Operations to define and align business processes with PLM technology capabilities
  • Collaborate with IS Architects and System Owners to craft a coordinated solution across PLM, ERP, document management, and manufacturing (MES) systems
  • Provide mentorship to project teams on defining business needs, articulating solutions and approaches for addressing business needs, and presenting business cases for proposed solutions.
  • Review project work throughout development to ensure quality and traceability to requirements and alignment to all quality management plans and standards. Participate in quality management reviews.


Secondary:
  • Perform system configurations and light customizations via Process Extensions (PX)
  • Identify and communicate any cross-area or cross-release issues that may impact other areas of the project
  • Assist run support teams as a point of critical issue
  • Assist in managing project budgets and external vendors
  • Mentor junior team members


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Information Systems experience

OR

Bachelor's Degree and 5 years of Information Systems experience

OR

Associate's degree and 10 years of Information Systems experience

OR

High school diploma/GED and 12 years of Information Systems experience

Preferred Qualifications:

  • Experience building productive working relationships with business clients
  • Experience with Agile/Scrum to deliver software/data solutions and working in product teams
  • Understanding of PLM architecture and configuration, including: interfaces, item libraries, engineering change orders (ECOs), Bills of Materials (BOM) management, and lifecycle states
  • Familiarity with Product Lifecycle Management practices in the biotech and pharmaceutical industries is preferable; experience with the composition and assembly of filing submissions within the Bio-Pharma lifecycle a plus
  • Experience with requirements management systems such as IBM DOORS or Dassault Systems a plus
  • Experience working with Big Data, Data Engineering, and Analytics/Data Visualizatoin a plus
  • Good overall understanding of business, manufacturing, and laboratory systems common in the pharmaceutical industry, as well as the integration of these systems through applicable standards
  • Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas
  • Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects to senior management in a clear and concise manner


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. The Research organization is the innovation engine discovering and developing next generation of innovative medicines to meet unmet medical needs

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.

PI118953649

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92399<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Florida - Tampa<br/><br/>Amgen is seeking a hardworking Business Analyst to build leading edge scientific applications with modern technology stacks that will be used by our business partners to drive Amgen's innovation across Operations. The outstanding candidate will join our Product Team to deliver compelling solutions and drive business outcomes aligned with the organization's goals.<br><br>The Specialist Information Systems (IS) Business Systems Analyst works within the Operations IS (OIS) group to support the Process Development business organization with a focus on Product Lifecycle Management (PLM) as part of an Operations-wide digital transformation.<br><br>The successful candidate will make fundamental improvements in how product information is managed, business processes are digitized/coordinated, and work flow is directed to help Amgen innovate, integrate, and accelerate advancement of Amgen's products.<br><br><b><b>Role Responsibilities </b></b><br><br><b>Primary: </b><br><ul><li>Drive solution design as part of the product team, eliciting and capturing requirements, user stories, workflows, and other relevant artifacts to deliver against encouraged business outcomes</li><li>Review functional and technical designs to identify areas of risk and/or missing requirements</li><li>Collaborate with the software engineers and architects to ensure all solutions are reliable, maintainable, and well-integrated into existing platforms</li><li>Develop and execute project plans, identify resource needs, proactively track risks/issues/decisions and understand how to execute IS projects according to time and budget commitments</li><li>Act as scrum leader - leading backlog grooming, sprint planning, story development, daily scrums, and retrospectives</li><li>Drive and facilitate all phases of delivery including intake, design, build, testing & validation</li><li>Assist the product teams in prioritizing work and clearing roadblocks</li><li>Ensure effective communication between business partners, technical team members and vendors to analyze detailed business requirements and implement solutions</li><li>Plan and execute on GxP system validation activities including change control, documentation installation qualification (IQ), and operational qualification (OQ)</li><li>Work with multi-functional representatives within Amgen Operations to define and align business processes with PLM technology capabilities</li><li>Collaborate with IS Architects and System Owners to craft a coordinated solution across PLM, ERP, document management, and manufacturing (MES) systems</li><li>Provide mentorship to project teams on defining business needs, articulating solutions and approaches for addressing business needs, and presenting business cases for proposed solutions.</li><li>Review project work throughout development to ensure quality and traceability to requirements and alignment to all quality management plans and standards. Participate in quality management reviews.</li></ul><br><br><b>Secondary:</b><br><ul><li>Perform system configurations and light customizations via Process Extensions (PX)<br></li><li>Identify and communicate any cross-area or cross-release issues that may impact other areas of the project</li><li>Assist run support teams as a point of critical issue</li><li>Assist in managing project budgets and external vendors</li><li>Mentor junior team members</li></ul><br><br><b><b>Basic Qualifications:</b></b><br><br>Doctorate Degree<br><br>OR<br><br>Master's Degree and 3 years of Information Systems experience<br><br>OR<br><br>Bachelor's Degree and 5 years of Information Systems experience<br><br>OR<br><br>Associate's degree and 10 years of Information Systems experience<br><br>OR<br><br>High school diploma/GED and 12 years of Information Systems experience<br><br><b><b>Preferred Qualifications:</b></b><br><br><ul><li>Experience building productive working relationships with business clients</li><li>Experience with Agile/Scrum to deliver software/data solutions and working in product teams</li><li>Understanding of PLM architecture and configuration, including: interfaces, item libraries, engineering change orders (ECOs), Bills of Materials (BOM) management, and lifecycle states</li><li>Familiarity with Product Lifecycle Management practices in the biotech and pharmaceutical industries is preferable; experience with the composition and assembly of filing submissions within the Bio-Pharma lifecycle a plus</li><li>Experience with requirements management systems such as IBM DOORS or Dassault Systems a plus</li><li>Experience working with Big Data, Data Engineering, and Analytics/Data Visualizatoin a plus</li><li>Good overall understanding of business, manufacturing, and laboratory systems common in the pharmaceutical industry, as well as the integration of these systems through applicable standards</li><li>Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas</li><li>Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present on complex subjects to senior management in a clear and concise manner</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and uses its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. The Research organization is the innovation engine discovering and developing next generation of innovative medicines to meet unmet medical needs<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> 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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/E5wWJNHM5nKWcY5bsXman"> <p>PI118953649</p>

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Posted: 2020-03-12 Expires: 2020-04-12

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Specialist Information Systems (IS) Business Analyst - Process Development

Amgen
Thousand Oaks, CA 91360

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