Senior Manufacturing Systems Engineer (Automation)

OW 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 Manufacturing Systems Engineer (Automation)

Live

What you will do

Let's do this. Let's change the world. As a member of the Amgen Manufacturing & Clinical Supplies - Facilities & Engineering (MCS-F&E) Automation team you will support Clinical and Commercial Drug Substance plant operations This includes complex and challenging system automation initiatives that require understanding of various automation platforms, integration between multiple platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.

Responsibilities include:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA).

• Lead/support technical root cause analysis, incident investigations, and trouble shooting on process control issues related to plant operations.

• Own change control records, CAPA records and deviations as it relates to Automation systems.

• Support functional area projects focused on improving process equipment, cleaning systems and utilities to ensure reliability of drug substance manufacturing facility.

• Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.

• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen's Ambitious goals.

• Maintain Data Integrity Assessments with the current Amgen and Industry standards.

• Support Review by Exception (RbE) functionality that includes product Batch records, cleaning, and sterilization systems, Audit trail and version control systems.

• Collaborate with Amgen Drug Substance Plant network to enhance the automation design for Drug Substance Plant Operations

• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.

• Day-to-day Operational Support including:

• Direct Manufacturing Support required for Critical Operations

• 24 x 7 Onsite/On Call as required.

• Trouble shooting Support to Manufacturing operations, cleaning systems, plant utilities and Building management system

• Automation System Administration

• Automation System Operating Systems (OS) security patching and HotFix assessments and rollout

• Daily manufacturing and engineering work center team meetings

• Preventative and corrective maintenance

• Automation System spare parts management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Automation professional We seek has these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of Manufacturing Automation Engineering experience

Or

Bachelor's degree and 5 years of Manufacturing Automation Engineering experience

Or

Associate degree and 10 years of Manufacturing Automation Engineering experience

Or

High school diploma / GED and 12 years of Manufacturing Automation Engineering experience

Preferred Qualifications:

• Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation technologies.

• Demonstrated hands-on experience in developing process control strategies in Clinical/Commercial Drug Substance Plant Operations.

• Familiarity with Upstream and Downstream unit operations.

• Direct knowledge of Automation design, experience in process control engineering and trouble shooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, and ultrafiltration/diafiltration, roller bottle processing, and integrating various OEM automation software.

• Demonstrated experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times; reduced plant utilities usage) related to Drug Substance Plant Operations.

• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope, and cost estimate development, case development, detailed design, engineering and validation documentation and project execution are a plus.

• The ideal individual must be a self-directed standout colleague ready to mentor. engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.

• Strong leadership, technical writing, and communication/presentation skills.

• Ability to perform independently, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.

• 3+ years' combined experience with the following:

• Emerson Delta-V DCS system

• Rockwell Automation SCADA and PLC Platform.

• Electronic Batch Reporting Systems Design and implementation experience.

• Process Control Network design including network segregation.

• Process Control Systems: Virtual Infrastructure design and implementation and ability to perform advanced trouble shooting activities in coordination with Amgen IS.

• System Integration using OPC, Profibus, Serial VIM, Ethernet and DeviceNet technologies.

• Compliance and regulatory requirements such as 21 CFR Part 11, S88, S95 and GAMP.

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.

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, 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 and bi-annual company-wide shutdowns

• 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.

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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.