Senior Manufacturing Systems Engineer (DeltaV/PLC)

BioSpace; Thousand Oaks (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Amgen is seeking a Senior Manufacturing Systems Engineer to support deltaV/PLC automation for Clinical and Commercial Drug Substance operations. You will work within the MCS-FE Automation team, tackling complex automation projects and lifecycle management in a regulated biopharma setting.

The role emphasizes problem-solving, cross-functional collaboration, and delivering continuous improvements across safety, reliability, and efficiency while maintaining data integrity and adherence to GMP

Qualifications

• PhD in a related field or Master’s with 3+ years automation engineering experience
• Bachelor’s degree with 5+ years automation experience
• Associate with 8+ years automation experience
• High school diploma with 10+ years automation experience

Responsibilities

• Develop and maintain process control automation solutions using DeltaV DCS, Rockwell PLC, HMI, and SCADA systems.
• Lead/root cause analyses and troubleshooting on process control issues related to plant operations.
• Own change control records, CAPA records and deviations for Automation systems.
• Support projects to improve process equipment, cleaning systems and utilities for reliability of Drug Substance manufacturing.
• Lead and support new technology introductions with automation assessments and qualification runs.
• Drive Continuous Improvement initiatives for safety, reliability, efficiency and environmental sustainability.
• Maintain Data Integrity Assessments per Amgen and industry standards.
• Support Review by Exception functionality including batch records, cleaning, sterilization, audit trails and version control.
• Collaborate with Amgen Drug Substance Plant network to enhance automation design.
• Ensure compliance and regulatory requirements for operation and maintenance and support inspections.

Skills

DeltaV DCS

Rockwell PLC/SCADA

Process control engineering

Automation troubleshooting

Regulatory compliance

Education

Doctorate degree

Master's degree in Manufacturing Automation Engineering

Bachelor's degree in Manufacturing Automation Engineering

Associate degree in Manufacturing Automation Engineering

High school diploma or GED

Tools

OPC

Profibus

Serial VIM

Industrial Ethernet

DeviceNet

HMI/SCADA

Job description

Join Amgens Mission of Serving Patients
At Amgen, if you feel like youre part of something bigger, its because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.
Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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-related conditions. As a member of the Amgen team, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Manufacturing Systems Engineer (DeltaV/PLC)

What You Will Do

Lets do this. Lets change the world. In this role 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 Amgens 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 On Call on a rotational basis.
• Troubleshooting 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

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
• Masters degree and 3 years of Manufacturing Automation Engineering experience OR
• Bachelors degree and 5 years of Manufacturing Automation Engineering experience OR
• Associate degree and 8 years of Manufacturing Automation Engineering experience OR
• High school diploma / GED and 10 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, chromatography, filtration and ultrafiltration/diafiltration, 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.

5+ 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.

What You Can Expect From 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, well 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.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

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. 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.