8 days old

Senior Associate Information Systems Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116957078
Amgen

Job ID: R-83604
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Florida - Tampa, US - Rhode Island - West Greenwich

Amgen is seeking to hire a Senior Associate Information Systems (IS) Engineer for Regulated Document Management (RDM) on an enterprise application based on Veeva Vault QualityDocs. The successful individual will play a key role in Amgen's RDM product team. You will coordinate with business representatives and be responsible for consulting, technically configuring and testing capabilities related to RDM. You will support the steady-state improvement of the application and provide continued technical hands-on expertise to Amgen business partners. You will help shape the multi-year RDM product roadmap in alignment with the platform vendor and the business partners.

You will be an active participant in all phases of the RDM Product Development Life Cycle (PDLC) including: business client expectation and requirement scope management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and supporting the development of business cases for proposed solutions.

This role entails the implementation, integration, and support of commercial off the shelf (COTS) application platforms focused on RDM for Life Sciences.

Role responsibilities:

  • Work with the business to understand business requirements and processes
  • Collaborate with other IS engineers to understand the application design and functionalities
  • Design and configure Veeva Vault QualityDocs platform to meet business needs
  • Design and execute test scripts (including automation design and execution)
  • Draft Installation Qualification (IQ) and Qualification Testing (QT) protocols
  • Document and close system defects
  • Partner with other test engineers to plan and document testing methods / test scripts to ensure full / sufficient testing of business requirements and system design
  • Perform business modeling, facilitate process mapping and business requirements gathering sessions for medium complex and multi-segment business processes, handle client expectations, configure system settings, and test the system configuration to ensure quality.


Basic Qualifications:

Master's degree

Or

Bachelor's degree and 2 years of Information Systems experience

Or

Associate's degree and 6 years of Information Systems experience

Or

High school diploma / GED and 8 years of Information Systems experience

Preferred Qualifications:

  • Solid grasp of RDM processes is required. This position requires extensive hands-on experience with and understanding of PDLC concepts and approaches, ability to run ongoing system improvements releases, and change control process.
  • Ability to navigate, facilitate and work within a complex matrix organization
  • Ability to work with internal business clients to understand their processes, lead scope of work/expectations and suggest/recommend IS solutions
  • Knowledge of, and experience with, implementing and supporting COTS Regulated Document Management applications in the life sciences industry
  • Hands-on configuration experience with Veeva QualityDocs strongly preferred.
  • A strong desire to grow into a hands-on configurator role is required
  • Experience with agile project methodologies and working in Product teams
  • Extensive experience in leading the IS change control process and running business client expectations
  • Extensive experience in leading the validation of a GxP application
  • Experience and/or understanding of private and multi-tenant cloud deployments and enterprise integrations
  • Excellent written, presentation, and verbal communication skills, including demonstrable experience presenting technology recommendations from a business perspective
  • Knowledge of the biotech/pharmaceutical industry and current approaches to GxP computer related systems


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.

PI116957078

<b>Amgen</b><br/><br/><b>Job ID: </b>R-83604<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Florida - Tampa, US - Rhode Island - West Greenwich<br/><br/>Amgen is seeking to hire a Senior Associate Information Systems (IS) Engineer for Regulated Document Management (RDM) on an enterprise application based on Veeva Vault QualityDocs. The successful individual will play a key role in Amgen's RDM product team. You will coordinate with business representatives and be responsible for consulting, technically configuring and testing capabilities related to RDM. You will support the steady-state improvement of the application and provide continued technical hands-on expertise to Amgen business partners. You will help shape the multi-year RDM product roadmap in alignment with the platform vendor and the business partners.<br><br>You will be an active participant in all phases of the RDM Product Development Life Cycle (PDLC) including: business client expectation and requirement scope management, process and systems analysis, requirements elicitation, articulating system solutions and approaches for addressing business needs, and supporting the development of business cases for proposed solutions.<br><br>This role entails the implementation, integration, and support of commercial off the shelf (COTS) application platforms focused on RDM for Life Sciences.<br><br><b><b>Role responsibilities:</b></b><br><br><ul><li>Work with the business to understand business requirements and processes</li><li>Collaborate with other IS engineers to understand the application design and functionalities</li><li>Design and configure Veeva Vault QualityDocs platform to meet business needs</li><li>Design and execute test scripts (including automation design and execution)</li><li>Draft Installation Qualification (IQ) and Qualification Testing (QT) protocols</li><li>Document and close system defects</li><li>Partner with other test engineers to plan and document testing methods / test scripts to ensure full / sufficient testing of business requirements and system design</li><li>Perform business modeling, facilitate process mapping and business requirements gathering sessions for medium complex and multi-segment business processes, handle client expectations, configure system settings, and test the system configuration to ensure quality.</li></ul><br><br><b><b>Basic Qualifications:</b></b><br><br>Master's degree<br><br>Or<br><br>Bachelor's degree and 2 years of Information Systems experience<br><br>Or<br><br>Associate's degree and 6 years of Information Systems experience<br><br>Or<br><br>High school diploma / GED and 8 years of Information Systems experience<br><br><b><b>Preferred Qualifications:</b></b><br><br><ul><li>Solid grasp of RDM processes is required. This position requires extensive hands-on experience with and understanding of PDLC concepts and approaches, ability to run ongoing system improvements releases, and change control process.</li><li>Ability to navigate, facilitate and work within a complex matrix organization</li><li>Ability to work with internal business clients to understand their processes, lead scope of work/expectations and suggest/recommend IS solutions</li><li>Knowledge of, and experience with, implementing and supporting COTS Regulated Document Management applications in the life sciences industry</li><li>Hands-on configuration experience with Veeva QualityDocs strongly preferred.</li><li>A strong desire to grow into a hands-on configurator role is required</li><li>Experience with agile project methodologies and working in Product teams</li><li>Extensive experience in leading the IS change control process and running business client expectations</li><li>Extensive experience in leading the validation of a GxP application</li><li>Experience and/or understanding of private and multi-tenant cloud deployments and enterprise integrations</li><li>Excellent written, presentation, and verbal communication skills, including demonstrable experience presenting technology recommendations from a business perspective</li><li>Knowledge of the biotech/pharmaceutical industry and current approaches to GxP computer related systems</li></ul><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/1wroNGc5Ln5rIAprUM52z"> <p>PI116957078</p>

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Posted: 2020-01-09 Expires: 2020-02-09

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Senior Associate Information Systems Engineer

Amgen
Thousand Oaks, CA 91360

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