Principal Manufacturing Systems Engineer, Upstream/Downstream Process Automation

Amgen

Confirmed live yesterday High trust

Quick summary

Work type: On-site
Location: Holly Springs, NC
Salary: $160,327–$216,913 / yr
Posted: 4 days ago
Freshness: Confirmed live yesterday
Nearby: 99+ roles within 25 mi

Market check

Salary context

Above market

How this pay compares to similar roles

Similar $162k

This role $189k

$118k most similar roles pay here $227k

This role pays more than 77% of similar roles. Most pay $140,000–$183,125 — the shaded band above. At the midpoint, this role pays about $189k versus about $162k for comparable roles.

Based on 240 similar postings.

Employer

About Amgen

Amgen is a leading biotechnology company that discovers, develops, manufactures, and delivers innovative human therapeutics, with products addressing conditions such as anemia, bone loss, inflammation, and cancer. Industry: Biotechnology & Pharmaceuticals

Amgen currently has 49 open roles on FindRole.

Listed pay typically runs $136,906–$185,227 across 45 roles with salary data.

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At a glance

TL;DR · Principal Manufacturing Systems Engineer, Upstream/Downstream Process Automation

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Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation joins the Facilities & Engineering group to serve as a subject matter expert in automation engineering for drug substance manufacturing. This role involves designing, commissioning, and qualifying process equipment while ensuring robust, compliant, and scalable solutions for 24/7 operations. The engineer will develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control Systems, manage system configurations, and lead continuous improvement initiatives regarding safety and reliability. Key responsibilities include troubleshooting systems, performing change assessments, and mentoring junior engineers to build technical capabilities. Required skills include expertise in industrial standards like 21 CFR Part 11 and GAMP, as well as experience with Process Analytical Technology and biopharmaceutical manufacturing processes including upstream bioreactors and downstream purification. The role addresses the challenge of integrating advanced automation into complex drug substance production environments.

Skills

Emerson DeltaV DCS Process Control Systems OPC Foundation Fieldbus Profibus IO-Link PAT 21 CFR Part 11 ASTM 2500 S88 S95 GAMP GMP CIP/SIP Commissioning and Qualification Data Integrity Bioprocessing

What you'll do

Design and implement automation solutions for upstream and downstream bioprocessing using Emerson DeltaV systems.
Lead the commissioning and qualification of process equipment in compliance with GMP requirements.
Provide 24/7 technical support, troubleshooting, and system ownership for manufacturing automation.
Manage automation change assessments, configuration changes, and engineering process qualification runs.
Drive continuous improvement initiatives to enhance safety, reliability, efficiency, and sustainability in manufacturing operations.
Mentor junior engineers and provide technical leadership to cross-functional teams.
Represent plant automation during regulatory inspections and audits while ensuring data integrity standards.
Influence automation strategy and standardization across the site and global network forums.

What we're looking for

Must have a Doctorate with 2 years experience, Master's with 4 years, Bachelor's with 6 years, Associate's with 10 years, or High School with 12 years of engineering experience.
Must have 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing resource allocation.
Degree in Electrical Engineering, Computer Science, Chemical Engineering, or Biotech Engineering (preferred).
Extensive experience with Emerson DeltaV, Process Control Network design, Virtual Infrastructure, OPC, Foundation Fieldbus, and Profibus (preferred).
Experience with IO-Link technology, PAT tools, and integrating OEM automation software/field instrumentation (preferred).
In-depth knowledge of 21 CFR Part 11, ASTM 2500, S88, S95, GAMP, GDP, and GMP (preferred).
Experience in regulated environments with familiarity with change control, non-conformances, CAPA, and commissioning/qualification (preferred).
Deep understanding of biopharmaceutical manufacturing processes including Upstream, Downstream, and CIP/SIP Skids (preferred).

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