Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Mfg Systems Engineer
What you will do
Let's do this. Let's change the world. In this vital role as a member of the Amgen Manufacturing & Clinical Supplies - Facilities & Engineering (MCS-F&E) Automation team you will support Clinical & Commercial Drug Product Plant Automation. The successful candidate will be required to support complex and challenging system automation initiatives that require solid understanding of analytical problem solving techniques, project management, lifecycle management and Operational Excellence.
This position requires an extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Developing process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
Support projects focused on improving process equipment/utilities/facilities -to- sophisticated unit operation skids to integrate new drug product manufacturing technologies into clinical/commercial facility.
Familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and computerized system administration job plans.
Testing of automation-based process equipment.
Ownership and administration of process control automation in a GMP regulated manufacturing setting.
Engage in process change control requests per established SOP and processes.
Lead technical root cause analysis, incident investigations, and trouble shooting on process control issues related to mechanical, electrical, instrumentation and control systems.
Support a safe working environment by aligning with all pertinent environmental health/safety practice, rules and regulations
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital professional we seek is a leader with these qualifications.
Basic Qualifications:
Master's degree
OR
Bachelor's degree and 2 years of Systems Engineering experience
OR
Associate's degree and 6 years of Systems Engineering experience
OR
High school diploma / GED and 8 years of Systems Engineering experience
Preferred Qualifications:
B.S or M.S. in Electrical Engineering, Chemical Engineering, Mechanical Engineering, or Biotech Engineering. Strong control system automation background focused specifically in design, installation, programming and validation of automated processes are essential.
2 or more years experience with Rockwell Automation Factory Talk & ControlLogix PLC Platform.
Ability to create, update and read electrical design packages including Software design specifications, URS, among other engineering and validation documentation.
Strong leadership, technical writing, and communication/presentation skills are required.
Work schedule flexibility as required to support 24/7 operations, requiring daily on-site and occasional after-hours engineering coverage.
Position requires a working knowledge of building automation systems, electronic batch records, PLC, OPC, Profibus, Ethernet/IP and DeviceNet technologies.
Working knowledge of Data Historian.
Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
Candidate should be experienced in change control, nonconformance, corrective and preventative actions, and validation practices.
Must be independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
Individual must be a standout colleague prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
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
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
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Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
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, disability status, or any other basis protected by applicable law.
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.
