Amgen Specialist IS Engineer - Automation Platforms in Woburn, Massachusetts
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 demonstrates 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.
As part of the Amgen’s Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.
Amgen is seeking a Senior Information Systems Engineer , internally known as a Specialist IS Automation Engineer , in our Woburn facility to join our team. As a senior member of the team, the Specialist will support complex and exciting IS initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Additionally, the Specialist provides project leadership and daily operational support.
Lead the Information systems platform roadmaps and lifecycle management.
Leads and supports capital project planning and implementation; including managing the ALRPM program.
Facilitates the application of sophisticated Information Systems principles in the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for capital projects of important scope and complexity.
Leads and assists technical root cause analysis, troubleshooting, incident management and investigations, and solving problems on computerized systems.
Oversees new product introductions or new technology introductions by performing engineering assessments, implementing system configuration changes, supporting engineering runs and testing activities.
Works closely with multiple disciplines, including manufacturing, laboratory, F&E, process engineering, utility operations, maintenance, quality assurance, and validation to handle a diverse portfolio of projects.
Provides technical support to commercial and clinical manufacturing.
Lead, develops and executes critical initiatives for long-range planning and lifecycle upgrades of various platforms with activities including leading 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 implementation.
Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
Technical support and issue resolution 24x7 on-call support of systems on a rotational based frequency.
Applies experience and knowledge of industry standard methodologies and tools to attain an innovative organization.
Master’s degree and 3 years of information systems or engineering experience
Bachelor’s degree and 5 years of information systems or engineering experience
Associate’s degree and 10 years of information systems or engineering experience
High School diploma / GED and 12 years of information systems or engineering experience
Bachelor’s Degree in Engineering or Information Systems
5+ years’ experience in a manufacturing support environment with 3+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries
3+ years’ combined experience with the following product platforms:MES and/or PI and/or laboratory systems and/or IS platforms
Familiarity with industry standards for software development life cycle methodologiesand21 CFR Part 11
Experience with validation and change control methodology
Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements
Effective verbal and written communication skills
Strong interpersonal skills with ability to work collaboratively in a team-based environment
Ability to lead multiple tasks and effectively set priorities
Strong computer skills and possess the ability to apply science-based thinking to practical applications
Energetic and technically-minded individual
We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
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.