Manufacturing Automation Engineer - Flexible, Impactful Biotech

Amgen Inc.; Holly Springs (NC); Híbrido; USD 105.000 - 143.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Discretionary annual bonus

Stock-based incentives

Flexible work model

Descripción de la vacante

Amgen Inc. in North Carolina seeks a Manufacturing Systems Engineer focused on automation for the new drug substance facility. You will develop and maintain DeltaV-based control systems and partner with capital projects to deliver robust automation for GMP operations.

The role requires a strong background in process controls, GMP/GAMP knowledge, and excellent documentation. You will own change controls, support QA validation, and help drive continuous improvement while working in a

Formación

• High School Diploma / GED with 8 years of Engineering experience OR
• Associate’s Degree with 6 years of Engineering experience OR
• Bachelor’s Degree with 2 years of Engineering experience OR
• Master’s Degree

Responsabilidades

• Develop and maintain the process control system on Emerson DeltaV DCS.
• Collaborate with key stakeholders and end-users to develop solutions using Amgen standard automation platform.
• Provide clear documentation for delivered solutions and processes.
• Support QA partners in performing computerized systems validation in a GxP environment.
• Perform Data Integrity Assessments (DIA) per Amgen standards.
• Support process automation systems to ensure design aligns with Amgen specifications, incorporates latest technology, and meets safety requirements.
• Support vendor FAT to ensure that control strategy and software code meet Amgen requirements.
• Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes.
• Support commissioning and qualification efforts including Automation IV/ACO in a fast-paced environment.
• Own and drive Change Controls, CAPAs, and Deviations.
• Support technical root cause analysis, incident investigations, and troubleshooting.
• Support projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility.
• Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
• Support day-to-day operations including rotational on-call support.
• Prepare/review SOPs and cGMP documents.

Conocimientos

Technical writing

Communication skills

Cross-functional collaboration

GAMP/GMP familiarity

Problem solving

Educación

Bachelor’s Degree in Engineering or related field

Associate’s Degree with 6 years experience

Master’s Degree

Herramientas

Emerson DeltaV DCS

OPC

Foundation Fieldbus

Profibus

Descripción del empleo

Amgen Inc. in North Carolina seeks a Manufacturing Systems Engineer focused on automation for the new drug substance facility. You will develop and maintain DeltaV-based control systems and partner with capital projects to deliver robust automation for GMP operations.

The role requires a strong background in process controls, GMP/GAMP knowledge, and excellent documentation. You will own change controls, support QA validation, and help drive continuous improvement while working in a