AddressHOW MIGHT YOU DEFY IMAGINATION?
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Senior Engineer – AML14 System Owner
Live
What you will do
Let’s do this. Let’s change the world. In this vital role, you will provide support and/or direct the characterization of processes, optimization strategies and/or equipment troubleshooting of operational issues in the operations, manufacturing, or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes and/or capital projects. Develops, coordinates, analyzes, and presents an interpretation of results for operational issues or engineering projects of significant scope and complexity within the AML14 Formulation and Filling (Vials & Syringes) operations.
Specific responsibilities include but are not limited to:
Provide solutions to a variety of technical problems of moderate scope and complexity.
Under minimal supervision will evaluate, select, and apply standard engineering techniques and procedures.
Perform assignments with clear and specific objectives, that could require investigation of limited number of variables.
Function as a technical expert on equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
Routinely audit the operational performance and regulatory compliance within the GMP’s and EHSS (Safety or Environmental) areas of a moderate number of equipment items or systems of significant complexity.
Communicate and collaborate with technical and management staff from different functional areas to develop requirements and recommendations for system modifications.
Supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Manage Quality Systems (Non-Conformances, CAPAs, ARMS) lifecycle (assessments, planning, execution, and closure) and support investigations as needed.
Owns and understands the Equipment Life Cycle (CMMS).
Obtain and review quotes for equipment modifications or installations and generate rudimentary project cost estimates and schedules.
Support non-standard shift organization and extended hours, as per business needs.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Sr. Engineer professional we seek is a collaborative individual contributor leader with these qualifications.
Basic Qualifications:
Doctorate degree in Engineering
OR
Master’s degree in Engineering and 2 years of Engineering support experience
OR
Bachelor’s degree in Engineering and 4 years of Engineering support experience
Beyond that, additional preferred qualifications are:
Educational Background in Mechanical, Electrical or Chemical Engineering
Equipment reliability experience.
Experience with equipment commissioning and qualification.
Isolator technology experience.
Solid understanding of pharmaceutical/biotech processes with the ability to interpret and apply GLPs and GMPs with 5+ years of industry experience.
Familiarity with validation processes and protocol writing with a basic technical report writing skills.
Excellent verbal and written communication in Spanish and English.
Comprehensive understanding of validation protocol execution requirements.
In-depth knowledge of validation processes and requirements as applied to new equipment installations.
Basic project management skills with the ability to delegate and manage the project work of others.
Skills in the following areas: Negotiation, Persuasion, Financial analysis tools, Collaboration, Project cost development, Computer literacy, Analytical problem solving & Conflict Resolution, Leadership, Team building & Schedule, and Management of contractors and vendors.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and an annual site shutdown
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
