Principal Manufacturing Systems Engineer (Delta-V, Rockwell)

Initial Therapeutics, Inc.; Thousand Oaks (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

An established industry player is seeking a Principal Manufacturing Systems Engineer to lead the charge in drug product manufacturing. This role focuses on ensuring operational success through advanced engineering and automation solutions. You will design and implement innovative systems, troubleshoot complex issues, and drive continuous improvement across manufacturing processes. Join a collaborative and innovative team that values your contributions and supports your professional growth while making a significant impact on patient lives. Embrace this opportunity to transform your career while transforming healthcare.

Benefits

Comprehensive employee benefits package

Retirement and Savings Plan

Flexible work models

Stock-based long-term incentives

Award-winning time-off plans

Discretionary annual bonus program

Qualifications

• Extensive experience in process automation within biopharmaceuticals.
• Strong background in engineering and configuration of automation systems.
• Proficient in troubleshooting and maintenance of electrical devices.

Responsibilities

• Provide technical leadership for drug substance manufacturing.
• Lead troubleshooting activities to enhance manufacturing uptime.
• Collaborate with cross-functional teams for continuous improvement.

Skills

Process Automation

Engineering Leadership

Troubleshooting

Project Management

Continuous Improvement

Education

Doctorate in Engineering

Masters in Engineering

Bachelors in Engineering

Associates in Engineering

High School Diploma/GED

Tools

Rockwell Automation

Emerson DeltaV

Programmable Logic Controllers (PLC)

Human Machine Interfaces (HMI)

Supervisory Control and Data Acquisition (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 missionto serve patients living with serious illnessesdrives 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. 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.

Principal Manufacturing Systems Engineer (Delta-V, Rockwell)

What you will do

Lets do this. Lets change the world. In this dynamic role the Principal Manufacturing Systems Engineer will ensure the success of Drug product manufacturing through an extensive understanding and solid background in engineering, configuration, programming, installation, commissioning, maintenance and trouble shooting of process controls, automation, electrical devices and field instrumentation technologies. The Principal Engineer will design, develop, and deliver innovative solutions enabling the advancement of Amgen Clinical and Commercial Drug Substance manufacturing processes.

Responsibilities include:

• Provide technical leadership for Day-to-day operational shift support for Upstream and Downstream Drug Substance manufacturing.
• Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
• Experience with the following product platforms.
• Rockwell Automation Factory Talk & ControlLogix PLC Platform
• Emerson DeltaV
• Day-to-day Operational Support:
• 24 x 7 Onsite/On Call: Day to Day Rotational Support
• Trouble shooting Support to Mfg. Operations
• Be an authority for Upstream and Downstream Unit operations by
• Leading advanced trouble shooting activities in partnership with the Plant Engineering & Maintenance teams to enhance manufacturing uptime through the highest reliability of Automation systems to Manufacturing.
• Being responsible to drive continuous improvement in partnership with Plant Engineering, Maintenance, Manufacturing, Process engineering and OEMs to drive operational efficiencies.
• Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
• Responsible to collaborate within the Amgen network to learn, implement and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.
• Responsible to maintain and provide necessary support for the associated Building Management systems and plant utilities (WFI, PUR, Clean Steam, UPS power distribution, Manufacturing Information System network infrastructure) operations.
• Responsible to maintain Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching of automation systems, servers & workstations.
• Executive presence & communicate complex automation topics in the simplest business language at various partner forums in the workplace: Daily plant Work Center Team (WCT) meetings, Weekly plant performance review, F&E WCT, & MCS SLT WCT, Purposeful Presence on the Floor (PPoF)
• As System Owner, be accountable and responsible to provide the necessary support during the internal and external regulatory audits.
• As Automation System Owner, lead new product introductions or new technology introductions in collaboration with multi-functional teams by performing engineering assessments, lead implementation of automation system configuration changes, and supporting engineering & Performance qualification runs.
• As System owner, provide Amgen User requirements to OEMs/System Integrators during the development of process control applications applying Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA), and development of Batch Reports using Manufacturing Execution System (MES) platform.
• Lead & implement Continuous improvement & Department Capital projects by developing the scope, budget, schedule, resource demand, develop & present the business case, obtain the management approvals, and communicate the progress to the key collaborators.
• Lead and support Capital projects. This role involves the application of advanced automation engineering principles in the design, specification, construction, startup, commissioning and qualification of process equipment and systems for capital projects of significant scope and complexity. Demonstrated understanding of project life cycles is preferred
• Candidate should be familiar with engineering processes from initial conceptualization through project turnover to operations. Responsible to develop & maintain Engineering Specifications, documents, drawings, and Standard Operational Procedures (SOP) including Administrative SOPs and Job Plans.
• Conversant with industry standards on quality and regulatory compliance requirements such as 21 CFR Part 11 (Data Integrity, User Security, System Disaster Recovery, Data Backup & Restore).
• Support a Safe working environment by aligning with all pertinent environmental health, safety & maintenance program practices, rules, and regulations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Engineering professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

Or

Masters degree and 6 years of Engineering experience

Or

Bachelors degree and 8 years of Engineering experience

Or

Associates degree and 10 years of Engineering experience

Or

High school diploma / GED and 12 years of Engineering experience.

Preferred Qualifications:

• Masters and/or Ph. D. in Chemical Engineering, Electrical Engineering, or related field.
• 10-15 years experience working in the process automation field within the biopharmaceutical industry.
• Ability to work independently and in small or large groups.
• Demonstrated proficiency in implementation of advanced process control applications in an industrial setting (e.g. Model Predictive Control, Adaptive Control).
• 5-10 years experience as an engineer or system administrator within the DeltaV Distributed Control System, Rockwell, ABB Robot, Mitsubishi Roller Bottle machine, Plant utilities, cleaning system and Building management system.
• Greater than 4 years experience leading matrixed teams.

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, 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, including remote and hybrid 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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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.

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