Amgen Manager Facilities Engineering Automation 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 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.
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 attitude, and an unyielding focus on safety, quality, and compliance.
The Manager of Automation reports directly to the Director of Facilities / Engineering / Automation position. The position is responsible for providing leadership to a subset of engineers within the Automation team focused on project execution and day-to-day support of the manufacturing and utility areas. The role includes providing technical oversight to automation project and task delivery, supporting maintenance and integration, ensuring effective day-to-day support, resolving problems and effectively directing their team to deliver on short and long-term Amgen goals.
Responsible for aiding the Director of Facilities / Engineering / Automation with FE Automation performance regarding:
Change Control and CAPA/Deviation resolution
Capital Project Execution
Operational Excellence Initiatives
GMP computer-related system owner responsibilities (validation, user access, 21 CFR Part 11 compliance, data integrity, backup/restore, disaster recovery).
Implementing and sustaining LEAN Concepts
Provides coaching, performance management, career development and mentoring to automation professionals to implement innovative and effective solutions.
Supports compliant computer system use, lifecycle management and business driven capability improvements for multi-product, commercial and clinical operations.
Supports inspection readiness programs for multiple regulatory agencies and acts as the Senior Manager’s back-up point of contact during inspections.
Helps manage and coordinate third-party service providers such as contractors, engineering firms and consultants, as well as internal, cross-functional area resources.
Provides Automation portfolio management including capital project planning and execution, tracking of cGMP commitments/deliverables such as Change Controls, Deviations and Corrective/Preventative Actions (CAPA).
Acts as Front-Line contact for site business partners, including Manufacturing (Cell Culture, Media, Harvest, Purification, Buffer), Facilities/Utilities (WFI, USPW, Clean Steam Generation and Distribution), Process Development Labs, QC Labs, and Warehouse/Storage areas.
Master’s degree and 3 years of IS and/or Automation experience
Bachelor’s degree and 5 years of IS and/or Automation experience
Associate’s degree and 10 years of IS and/or Automation experience
High school diploma / GED and 12 years of IS and/or Automation experience
Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
3+ years of supervisory experience with demonstrated skills in staff engagement, coaching/mentoring and professional development.
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.
Strong leadership, project management, negotiation, planning, and change management skills.
Experience working cross-functionally and building collaborative working relationships; interfacing effectively with clients to help resolve issues.
Ability to deal with complexity and ambiguity, ability to collect, digest and assemble information to enable and facilitate decision-making.
Results oriented, strong adherence to timelines.
Possesses personal leadership qualities that inspire trust, respect, credibility and confidence of peers and colleagues.
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.