Manufacturing Systems Engineer: Automation - PLC

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 80,000 - 120,000; Full time

Job summary

Initial Therapeutics, Inc. in Holly Springs, North Carolina is seeking a Manufacturing Systems Engineer to develop and maintain automation solutions for GMP Drug Substance Plant operations. The role necessitates a strong engineering background, with responsibilities including supporting standalone system implementation and collaborating with teams to enhance automation. Ideal candidates will hold a Bachelor's or Master's degree in engineering and have substantial experience in controls engineering and GMP environments, contributing to innovative processes in a cutting-edge pharmaceutical setting.

Qualifications

• 8 years of engineering experience or relevant degree with lesser experience.
• Direct knowledge of PLC design and controls engineering.
• Hands-on experience in process control strategies.

Responsibilities

• Develop and maintain automation solutions.
• Support standalone system implementation and startup.
• Collaborate with business partners to optimize automation solutions.

Skills

PLC design

GMP biopharmaceutical production

Controls engineering

Technical writing

Communication skills

Education

Bachelor's Degree

Masters Degree

Electrical Engineering or Computer Science

Tools

Allen Bradley PLCs

Siemens PLCs

Emerson DeltaV system

Job description

Manufacturing Systems Engineer: Automation

As a Manufacturing Systems Engineer, you will work with a group of automation engineers responsible for building and maintaining automation systems supporting GMP Drug Substance Plant operations.

In this vital role within Facilities & Engineering Automation you will collaborate with the capital project team to deliver robust automation systems for the new plant, including utilities and standalone systems, requiring integration across platforms and project lifecycle management.

Be part of Amgen's newest drug substance manufacturing plant featuring advanced disposable technologies and industry 4.0 capabilities, part of the plan to be carbon neutral by 2027.

What you will do

• Develop and maintain automation solutions using various PLCs such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system.
• Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLCs and interface hardware.
• Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc.
• Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
• Assist in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems.
• Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions.
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.

Ongoing operations

• Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
• Support technical root cause analysis, incident investigations, and troubleshooting on standalone systems.
• Support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Assist with Day-to-Day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management.
• Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively.

Basic Qualifications

• High School Diploma / GED and 8 years of Engineering experience OR
• Associates Degree and 6 years of Engineering experience OR
• Bachelors Degree and 2 years of Engineering experience OR
• Masters Degree

Preferred Qualifications

• Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering.
• Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and integrating various OEM automation software.
• Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies.
• Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88, and S95.
• Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
• Hands‑on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
• Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations.
• The ideal individual must be a self‑directed great teammate ready to embrace a team‑based culture that relies on collaboration for effective decision‑making.
• Strong technical writing and communication/presentation skills.

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 support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Equal Opportunity Employer

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.