26 days old

Lead Specialist IS Engineer

Amgen
West Greenwich, RI 02817
  • Job Code
    114880609
Amgen

Job ID: R-86097
Location: Rhode Island, RI, US

Amgen is seeking a Lead Specialist IS (Information Systems) Engineer in our state-of-the-art Rhode Island facility to join the Information Systems team and who will report to the Senior Manager of Information Systems and will provide direct support as a technical expert to our new manufacturing plant at the West Greenwich site.

As a senior member of the Information Systems team, the Lead Specialist, known internally as the Specialist IS Engineer, will support complex and challenging business systems initiatives that require understanding of analytical problem-solving techniques, business and systems analysis expertise, project management, lifecycle management and Operational Excellence. Additionally, the Specialist is responsible for providing project leadership and daily operational support to the Information Systems team at the Amgen Rhode Island site. Further, the Specialist IS Engineer plays a critical role in building and maintaining strong business partnership with the manufacturing site leadership team and is a liaison project workstream and global teams.

Key Responsibilities of the Lead Specialist IS Engineer include:
  • Leads and supports of Information Systems capital projects
  • Facilitates the application of advanced information systems principles in the design, specification, construction, startup, and validation of process and GMP computerized systems for capital projects of significant scope and complexity
  • Leads and supports technical root cause analysis, incident investigations, and troubleshooting issues related to computerized systems
  • Communicates proactively with multiple levels within the organization, highlighting issues and proposing solutions
  • Ensures that systems are implemented and maintained in compliance with 21 CFR Part 11 and follows the IS Project Management Lifecycle Methodology
  • Leads technical root cause analysis, incident investigations, and troubleshooting on computerized systems
  • Analyzes problems, develops and proposes technical solutions in a scientific manner using data-driven techniques and analyses
  • Works closely with multiple disciplines, including manufacturing, automation, quality control, process development, quality assurance, and validation to manage a diverse portfolio of projects
  • Provides technical support to commercial and clinical manufacturing as needed
  • Develops and executes strategic initiatives for long-range planning and lifecycle upgrades of various platforms with activities including managing a 5-year roadmap of systems, presenting high level scope and cost estimates to executives for annual capital funding plan, and project management of initiatives once approved for execution
  • Provides technical support and issue resolution 24x7 on-call support of information systems on a rotational based frequency
  • Applies experience and knowledge of industry best practices and tools to attain an innovative organization


Basic Qualifications:

Doctorate degree

OR

Master's degree and 2 years of Engineering and/or Information Systems experience

OR

Bachelor's degree and 4 years of Engineering and/or Information Systems experience

OR

Associate's degree and 10 years of Engineering and/or Information Systems experience

OR

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

Preferred Qualifications :

  • Bachelor's degree or master's degree in Engineering, Information Systems, or related technological field
  • 5+ years' experience in Information Systems in a manufacturing support environment
  • 3+ years' experience in the Pharmaceutical or Biotechnology industries
  • Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements, implementation experience of software and hardware components
  • Familiarity with industry standards for, software development life cycle methodologies, 21 CFR Part 11, Validation, and GAMP
  • Strong leadership, technical writing, and communication/presentation skills
  • Experience with Tech Transfer, Process Design, and Commissioning
  • Experience with validation and change control methodology
  • Management and coordination of third-party organizations such as contractors, engineering firms and consultants.
  • Previous experience leading strategic planning efforts and the implementation of plans for coordinating multi-site enterprise-wide system solutions.


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 leverages 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.

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.

PI114880609

<strong>Amgen</strong><br /><br /><strong>Job ID: </strong>R-86097<br /><strong>Location: </strong>Rhode Island, RI, US<br /><br />Amgen is seeking a Lead Specialist IS (Information Systems) Engineer in our state-of-the-art Rhode Island facility to join the Information Systems team and who will report to the Senior Manager of Information Systems and will provide direct support as a technical expert to our new manufacturing plant at the West Greenwich site.<br /><br />As a senior member of the Information Systems team, the Lead Specialist, known internally as the Specialist IS Engineer, will support complex and challenging business systems initiatives that require understanding of analytical problem-solving techniques, business and systems analysis expertise, project management, lifecycle management and Operational Excellence. Additionally, the Specialist is responsible for providing project leadership and daily operational support to the Information Systems team at the Amgen Rhode Island site. Further, the Specialist IS Engineer plays a critical role in building and maintaining strong business partnership with the manufacturing site leadership team and is a liaison project workstream and global teams.<br /><br /><strong> Key Responsibilities of the </strong><strong> Lead Specialist IS Engineer </strong><strong> include: </strong><br /> <ul> <li>Leads and supports of Information Systems capital projects</li> <li>Facilitates the application of advanced information systems principles in the design, specification, construction, startup, and validation of process and GMP computerized systems for capital projects of significant scope and complexity</li> <li>Leads and supports technical root cause analysis, incident investigations, and troubleshooting issues related to computerized systems</li> <li>Communicates proactively with multiple levels within the organization, highlighting issues and proposing solutions</li> <li>Ensures that systems are implemented and maintained in compliance with 21 CFR Part 11 and follows the IS Project Management Lifecycle Methodology</li> <li>Leads technical root cause analysis, incident investigations, and troubleshooting on computerized systems</li> <li>Analyzes problems, develops and proposes technical solutions in a scientific manner using data-driven techniques and analyses</li> <li>Works closely with multiple disciplines, including manufacturing, automation, quality control, process development, quality assurance, and validation to manage a diverse portfolio of projects</li> <li>Provides technical support to commercial and clinical manufacturing as needed</li> <li>Develops and executes strategic initiatives for long-range planning and lifecycle upgrades of various platforms with activities including managing a 5-year roadmap of systems, presenting high level scope and cost estimates to executives for annual capital funding plan, and project management of initiatives once approved for execution</li> <li>Provides technical support and issue resolution 24x7 on-call support of information systems on a rotational based frequency</li> <li>Applies experience and knowledge of industry best practices and tools to attain an innovative organization</li> </ul> <br /><br /><strong> Basic Qualifications: </strong><br /><br />Doctorate degree<br /><br />OR<br /><br />Master's degree and 2 years of Engineering and/or Information Systems experience<br /><br />OR<br /><br />Bachelor's degree and 4 years of Engineering and/or Information Systems experience<br /><br />OR<br /><br />Associate's degree and 10 years of Engineering and/or Information Systems experience<br /><br />OR<br /><br />High school diploma / GED and 12 years of Engineering and/or Information Systems experience<br /><br /><strong> Preferred Qualifications </strong><strong> : </strong><br /><br /> <ul> <li>Bachelor's degree or master's degree in Engineering, Information Systems, or related technological field</li> <li>5+ years' experience in Information Systems in a manufacturing support environment</li> <li>3+ years' experience in the Pharmaceutical or Biotechnology industries</li> <li>Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements, implementation experience of software and hardware components</li> <li>Familiarity with industry standards for, software development life cycle methodologies, 21 CFR Part 11, Validation, and GAMP</li> <li>Strong leadership, technical writing, and communication/presentation skills</li> <li>Experience with Tech Transfer, Process Design, and Commissioning</li> <li>Experience with validation and change control methodology</li> <li>Management and coordination of third-party organizations such as contractors, engineering firms and consultants.</li> <li>Previous experience leading strategic planning efforts and the implementation of plans for coordinating multi-site enterprise-wide system solutions.</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 leverages 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.<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/DoMLWzsV8Xb4UYwysqmY6"> <p>PI114880609</p>

Categories

Posted: 2019-10-25 Expires: 2019-11-25

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Lead Specialist IS Engineer

Amgen
West Greenwich, RI 02817

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast