Senior Manufacturing Automation Engineer – BAS/PLC (Remote)

BioSpace

Holly Springs (NC)

On-site

USD 110,000 - 150,000

Full time

6 days ago

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Benefits offered by this job

Retirement plan

Stock-based incentives

Discretionary annual bonus

Flexible work models

Job summary

Amgen seeks a Senior Manufacturing Systems Engineer: Automation - BAS / PLC to provide technical leadership for building automation systems, PLC-based process control, and related facilities engineering. You will work with the F&E Automation team to deliver robust control strategies and ensure validated, compliant operations in a modern biotech facility.

The role requires strong collaboration across cross-functional teams, with a focus on commissioning, qualification, change control, and

Qualifications

Experience with GMP biopharmaceutical facilities and validated systems.
Strong knowledge of 21 CFR Part 11, ASTM 2500, S95, GAMP 5, GDP.
Ability to lead FATs and manage vendor testing.
Experience with qualification and commissioning of BAS and PLC systems.
Excellent documentation and change control skills.

Responsibilities

Site design, construction, start-up, and operational readiness for automation systems.
Collaborate with stakeholders to define process requirements and develop automation solutions.
Develop and maintain engineering documentation and procedures; support computerized systems validation.
Lead FAT and ensure control strategy meets Amgen requirements.
Provide day-to-day operational support for BAS and PLC equipment.
Own Change Controls, CAPAs, and deviations for automation systems.
Drive continuous improvement of building equipment systems.