Senior Manufacturing Systems Engineer: Automation - DeltaV Job Holly Springs area,North Carolina USA,Engineering

Senior Manufacturing Systems Engineer – Automation - DeltaV

Amgen is seeking a Senior Manufacturing Systems Engineer to provide automation technical leadership for the GMP Drug Substance Plant Operations.

What You Will Do

Provide automation technical leadership to a team of automation engineers maintaining automation systems for the new plant. Work with capital projects, SME, and business partners to deliver robust process automation solutions using Emerson DeltaV distributed control system (DCS).

Develop and maintain the process control system on Emerson DeltaV DCS.
Work with process SMEs to transform requirements into automated solutions.
Collaborate with business partners to improve workflow and productivity.
Document solutions, support QA, and maintain Data Integrity Assessments in a GxP environment.
Build business processes to support project scope and develop engineering policies and procedures.
Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO).

Ongoing Operations

Own and drive change controls, CAPAs, and deviations.
Lead functional area projects focused on improving process equipment, utilities, and facilities.
Conduct technical root cause analysis, incident investigations, and troubleshooting of process control issues.
Lead new product introductions and new technology introductions through automation assessments and configuration changes.
Provide day‑to‑day operational support: 24/7 onsite/on‑call support, troubleshooting, preventive and corrective maintenance, system administration, and spare parts management.
Prepare and review SOPs and cGMP documents.
Continuously seek innovative ways to improve business processes.

What We Expect Of You Basic Qualifications

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

Preferred Qualifications

Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
Direct knowledge of automation system design and process control engineering in GMP biopharma facilities.
Experience with Emerson DeltaV DCS, process control network design, OPC, Foundation Fieldbus, Profibus, Device Net;
DeltaV Live preferred.
Knowledge of GAMPs, GMPs, 21 CFR Part 11, ASTM 2500, S88, and S95.
Experience in capital project lifecycle management.
Hands‑on experience developing process control strategies for new product introduction and new technology deployment.
Track record of continuous improvement in safety, reliability, and productivity.
Self‑directed team player able to mentor staff and collaborate across functions.
Strong leadership, technical writing, and communication skills.

What You Can Expect Of Us

Amgen offers competitive total rewards, a collaborative culture, and support for professional growth. Benefits include competitive salary, comprehensive rewards plans, and a supportive work environment.

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 application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.

Please contact us to request accommodation.

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