Senior Automation Architect: BAS & PLC for Biotech

BioSpace; Holly Springs (NC); Hybrid; USD 120.000 - 170.000; Vollzeit

Benefits dieser Stelle

Remote/hybrid work

Competitive benefits

Bonus potential

Stock awards

Zusammenfassung

Amgen is seeking a Senior Manufacturing Systems Engineer – Automation to provide technical leadership for building automation systems (BAS) and PLC-based equipment in the new drug substance facility. You will collaborate with the capital project team to deliver robust automation solutions, drive commissioning and validation activities, and ensure compliance with GMP and 21 CFR Part 11 standards.

You will own system administration, documentation, change controls, and performance improvements

Qualifikationen

• Bachelor's degree in engineering or related field; multiple levels of advanced degrees acceptable.
• Engineering experience with GMP biopharmaceutical facilities is preferred.
• Strong leadership, communication, and cross-functional collaboration skills.

Aufgaben

• Lead automation engineers to build and maintain BAS and PLC-based systems for drug substance plant operations.
• Collaborate with capital projects to deliver robust automation solutions and integrate equipment.
• Develop and maintain documentation and validation-related procedures in a GxP environment.
• Drive commissioning, qualification, and FAT activities with suppliers and internal teams.
• Ensure network connectivity and monitoring for standalone PLC systems and centralized control.
• Support change controls, CAPAs, and deviations to ensure reliability and compliance.
• Provide day-to-day operational support and on-call coverage for BAS and skid equipment.
• Foster continuous improvement in utility and building automation systems.

Kenntnisse

Automation engineering

GMP knowledge

Leadership

Cross-functional teamwork

Documentation

Ausbildung

Bachelor's in Engineering

Master's in Engineering

Doctorate

Tools

BAS

PLC programming

IV/ACO

Change controls

Jobbeschreibung

Amgen is seeking a Senior Manufacturing Systems Engineer – Automation to provide technical leadership for building automation systems (BAS) and PLC-based equipment in the new drug substance facility. You will collaborate with the capital project team to deliver robust automation solutions, drive commissioning and validation activities, and ensure compliance with GMP and 21 CFR Part 11 standards.

You will own system administration, documentation, change controls, and performance improvements