Senior Manufacturing Systems Engineer - PLC Systems

Initial Therapeutics, Inc.; Holly Springs (NC); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive benefits

Collaborative culture

Career growth opportunities

Job summary

Initial Therapeutics, Inc. is seeking a Senior Manufacturing Systems Engineer to lead projects in automation for advanced drug substance production. The ideal candidate will possess extensive experience in PLC programming and process control in a biopharmaceutical setting.

This role involves collaboration with various teams to ensure on-time facility startup, operational support, and the integration of new manufacturing technologies. Strong leadership and technical skills are essential for mentoring the engineering staff.

Qualifications

• 10 years of engineering experience or relevant academic qualifications.
• Experience with process control engineering in biopharmaceutical environments.
• Extensive knowledge in implementing automation technologies.

Responsibilities

• Lead technical projects for manufacturing automation.
• Collaborate with teams for operational readiness and system integration.
• Manage and troubleshoot PLC-based systems for efficiency.

Skills

PLC programming

Automation system design

Troubleshooting

Technical writing

Leadership

Education

Bachelor’s Degree in Engineering

Master’s Degree in Engineering

PhD in Engineering

Tools

Rockwell platforms

Automation software

Job description

Senior Manufacturing Systems Engineer (PLC)

In this vital role as a member of the Facilities & Engineering (F&E) group, you will lead technical projects, drive innovation, and support PLC‑based processes and utility skid equipment automation needs. You will solve complex engineering problems and ensure the company’s engineering efforts align with strategic objectives. You will also provide leadership and guidance to the Automation Engineering team supporting 24/7 manufacturing and facility operations.

You will partner closely with the capital project team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role will develop domain expertise to support operations upon start‑up, focusing on manufacturing automation.

Job responsibilities include:

Site design, construction, start‑up, and operational readiness

• Provide support to the capital project team with a strong focus on safety and on‑time facility start‑up.
• Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions for PLC‑based systems.
• Work with platform leads to ensure standalone PLC‑based systems are designed with the proper network connectivity and system‑to‑system communication to enable centralized monitoring and alarming.
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).
• Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls.
• Develop and maintain detailed specifications, SOPs and operating standards that impact multiple organizational units.
• Provide mentoring to develop and accelerate site technical automation capabilities.

Site Operations

• Act as system owner for standalone PLC‑based systems.
• Manage day‑to‑day operational support including 24×7 onsite/on‑call operational support, troubleshooting support to plant and manufacturing operations, preventive and corrective maintenance, system administration, and automation system spare parts management.
• Lead and support functional area projects focused on improving equipment/utilities/facilities as well as capital projects to integrate new drug substance manufacturing technologies into the facility.
• Lead and support technical root‑cause analysis, incident investigations, and troubleshooting on process control issues related to plant operations.
• Lead and 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.
• Prepare and review Standard Operating Procedures (SOP) and cGMP documents.
• On‑site and up to 10% domestic/international travel.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with the following qualifications.

Basic Qualifications

• High School Diploma / GED and 10 years of Engineering experience OR
• Associate’s Degree and 8 years of Engineering experience OR
• Bachelor’s Degree and 4 years of Engineering experience OR
• Master’s Degree and 2 years of Engineering experience OR
• Doctorate Degree

Preferred Qualifications

• Degree in Electrical Engineering or Computer Science, Chemical Engineering or Biotech Engineering.
• Extensive experience with process and utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies such as Rockwell platforms.
• Direct knowledge of integrating various OEM automation software and field instrumentation technologies.
• Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation.
• Experience in programming, design, installation and lifecycle management of PLC and field device/instrumentation technologies.
• Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
• In‑depth knowledge of industry standards such as 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP.
• Experience in Capital Project Lifecycle Management including conceptual design, basis of design, detailed design, implementation, and validation.
• The ideal individual must be a self‑directed team player ready to mentor and develop engineering staff and embrace a team‑based culture that relies on collaboration for effective decision‑making.
• Strong leadership, technical writing, and communication/presentation skills.

What you can expect of us

From competitive benefits to a collaborative culture, we support your professional and personal growth and well‑being.

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.