Senior Manufacturing Systems Engineer (Automation)

📍 Job Overview

• Job Title: Senior Manufacturing Systems Engineer (Automation)
• Company: Amgen
• Location: Holly Springs, North Carolina, United States
• Job Type: On-site
• Category: Engineering
• Date Posted: 2025-06-27
• Experience Level: 5-10 years
• Remote Status: On-site

🚀 Role Summary

• Lead automation technical efforts for GMP Drug Substance Plant Operations
• Collaborate with stakeholders to develop and maintain automation solutions
• Ensure compliance with industry standards and regulations
• Provide technical leadership and mentorship to a team of automation engineers
• Drive continuous improvement and operational excellence

💻 Primary Responsibilities

• Site Design, Construction, Start-up, and Operational Readiness:

  • Collaborate with key stakeholders to understand process requirements and develop automation solutions using Amgen's standard automation platform for building automation systems and process/utility skid equipment.
  • Develop and maintain engineering and maintenance documentation, and support computerized systems validation processes in a GxP environment.
  • Support commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment.
  • Collaborate with cross-functional teams to develop commissioning and qualification plans/strategies for building automation systems and process/utility skid equipment.
  • Ensure standalone PLC-based systems are designed with proper network connectivity for centralized monitoring and alarming.
  • Support design phases to ensure equipment aligns with Amgen's specifications, incorporates the latest technology, and meets safety requirements.
  • Lead vendor's Factory Acceptance Test (FAT) and ensure control strategy and software code meet Amgen's requirements.
  • Understand manufacturing operations and ensure control strategy aligns with existing operations for retrofit projects.

• Site Operations:

  • Act as system owner for building automation systems and standalone PLC-based systems, responsible for system administration, maintenance procedures and job plans, spare parts, and engineering documentation.
  • Own and drive to completion Change Controls, CAPAs, and Deviations for assigned automation systems to ensure reliability and compliance.
  • Lead and support functional area projects focused on improving process equipment/utilities/facilities and large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility.
  • Drive continuous improvement for utility and building equipment systems to improve operational workflows, safety, reliability, efficiency, and sustainability.
  • Lead/support technical root cause analysis, incident investigations, and troubleshooting on utilities and building automation systems.
  • Provide day-to-day operational support, including rotational on-call operational support for building automation systems and process/utility skid equipment.
  • Perform and maintain data integrity assessments in accordance with current Amgen Global Standard procedures and applicable standards.

🎓 Skills & Qualifications

Education:

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

Preferred Qualifications:

• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field.
• Direct knowledge of BMS design, experience in building control engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation.
• Experience with building automation systems and process/utility skid equipment, and direct knowledge of integrating various OEM automation software and field instrumentation technologies.
• Knowledgeable of industry standards such as 21 CFR Part 11, ASTM 2500, S95, GAMP 5, and GDP.
• Experience in programming, design, installation, and lifecycle management of building automation controls, PLC, and field device/instrumentation technologies.
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment.
• Strong leadership, technical writing, and communication/presentation skills.
• Ability for domestic/international travel as needed.

📊 Web Portfolio & Project Requirements

• Not applicable for this role

💵 Compensation & Benefits

Salary Range:

• $119,195 - $147,867 per year

Benefits:

• Comprehensive Employee Benefits Package
• Retirement and Savings Plan
• Group Medical Coverage
• Dental Coverage
• Vision Coverage
• Life Insurance
• Disability Insurance
• Flexible Spending Accounts
• Discretionary Annual Bonus Program
• Stock-Based Long-Term Incentives
• Award-Winning Time-Off Plans
• Flexible Work Models

Working Hours:

• Full-time, 40 hours per week

🎯 Team & Company Context

Company Culture:

• Industry: Biotechnology
• Company Size: Large (10,000+ employees)
• Founded: 1980

Team Structure:

• The Facilities & Engineering (F&E) Automation team works closely with the capital project team to deliver robust building automation systems and PLC-based process/utility skid equipment for the new plant.
• The team collaborates with cross-functional teams, including process engineers, mechanical engineers, and project managers, to ensure automation solutions meet process requirements and industry standards.

Development Methodology:

• Amgen follows industry-standard project management methodologies, such as Agile/Scrum, for drug substance manufacturing projects.
• The company emphasizes data-driven decision-making, continuous improvement, and a culture of innovation.

Company Website: www.amgen.com

📝 Enhancement Note: Amgen's culture is collaborative, innovative, and science-based, with a strong focus on serving patients and improving the quality of life for people around the world.

📈 Career & Growth Analysis

Web Technology Career Level:

• Senior Manufacturing Systems Engineer (Automation) is an advanced role requiring significant experience in automation, building control engineering, and GMP biopharmaceutical production facility operations.

Reporting Structure:

• The Senior Manufacturing Systems Engineer (Automation) reports directly to the Manager of Facilities & Engineering (Automation) and works closely with the capital project team, process engineers, mechanical engineers, and project managers.

Technical Impact:

• This role has a significant impact on GMP Drug Substance Plant Operations, ensuring the availability, reliability, and performance of automation systems and platforms.
• The Senior Manufacturing Systems Engineer (Automation) drives technical innovation, continuous improvement, and operational excellence in automation systems, ultimately contributing to Amgen's mission of serving patients.

Growth Opportunities:

• Technical Skill Development: Amgen offers opportunities for technical skill development, including training programs, workshops, and mentorship to help engineers advance their careers in automation, building control engineering, and related fields.
• Technical Leadership: With experience and strong performance, engineers can progress to technical leadership roles, managing teams and driving strategic initiatives in automation and related areas.
• Architecture Decision-Making: As engineers gain experience and expertise, they may have the opportunity to influence architecture decisions, shaping the future of Amgen's automation systems and platforms.

📝 Enhancement Note: Amgen's commitment to continuous learning and professional development enables engineers to grow their careers and make a lasting impact on the company's mission.

🌐 Work Environment

Office Type:

• On-site, with a collaborative and innovative work environment focused on serving patients and improving the quality of life for people around the world.

Office Location(s):

• Holly Springs, North Carolina, United States

Workspace Context:

• Amgen provides engineers with modern, well-equipped workspaces, including multiple monitors, testing devices, and access to relevant software and tools.
• The company fosters a collaborative work environment, with open communication and cross-functional team interaction.

Work Schedule:

• Full-time, with a standard workweek of 40 hours, Monday through Friday.
• Amgen offers flexible work arrangements, including remote work options, for certain positions and teams.

📝 Enhancement Note: Amgen's work environment is designed to support engineers' professional growth, collaboration, and innovation, ultimately contributing to the company's mission of serving patients.

📄 Application & Technical Interview Process

Interview Process:

• Process Step 1: Technical preparation recommendations and coding/configuration assessment focus
• Process Step 2: Web architecture expectations and system design discussion
• Process Step 3: Web development team interaction and cultural fit assessment
• Process Step 4: Final evaluation criteria and technical impact discussion

Portfolio Review Tips:

• Not applicable for this role

Technical Challenge Preparation:

• Challenge Preparation 1: Typical automation exercise format and expectations
• Challenge Preparation 2: Time management and solution architecture for automation challenges
• Challenge Preparation 3: Communication and technical explanation articulation for automation concepts

ATS Keywords:

• Automation, Engineering, Building Automation Systems, PLC Programming, GMP Compliance, Data Integrity, Project Management, Cross-Functional Collaboration, Technical Writing, Troubleshooting, Root Cause Analysis, Continuous Improvement, Vendor Management, Safety Standards, Operational Support, Commissioning

📝 Enhancement Note: Amgen's interview process focuses on assessing candidates' technical skills, problem-solving abilities, and cultural fit within the company's collaborative and innovative work environment.

📌 Application Steps

To apply for this Senior Manufacturing Systems Engineer (Automation) position:

• Submit your application through the application link
• Prepare for technical interviews by reviewing automation concepts, practicing coding/configuration assessments, and familiarizing yourself with Amgen's automation systems and platforms
• Research Amgen's company culture, mission, and values to demonstrate your fit and enthusiasm for the role
• Prepare for on-site interviews by rehearsing your responses to common interview questions and practicing your communication skills

⚠️ Important Notice: This enhanced job description includes AI-generated insights and industry-standard assumptions. All details should be verified directly with Amgen before making application decisions.