Senior Manufacturing Systems Engineer: Automation - BAS / PLC

Amgen • Holly Springs, NC

1d • $115,495 - $156,257

About The Position

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Requirements

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

Nice To Haves

• Degree in Electrical Engineering or 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 and integrating various OEM automation software.
• Experience with building automation systems and process and 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 with requirements such as 21 CFR Part 11, ASTM 2500, and S95.
• The ideal individual must be a self-directed team player able to work cross-functionally.
• Strong leadership, technical writing, and communication/presentation skills.
• Ability for domestic/international travel as needed.

Responsibilities

• Provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
• Work hand in hand with the capital project team to deliver robust building automation systems (BAS) and PLC based process and utility skid equipment to operate the new plant.
• Collaborate with key stakeholders to understand key process requirements and synthesize feedback from clients, customers or end-users to develop the best automation solutions using Amgen standard automation platform for building automation systems and process and utility skid equipment.
• Develop and maintain engineering and maintenance documentation and associated procedures for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
• Maintain Data Integrity Assessments with the current Amgen and industry standards.
• 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 a robust commissioning and qualification plan and/or qualification strategy for the building automation systems and process and utility skid equipment in support of the project delivery.
• Work with platform leads to ensure standalone PLC based systems are designed with the proper network connectivity to enable 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 FAT (for the automation testing) and ensure that control strategy and software code meet Amgen’s requirements.
• Understand the manufacturing operation and ensure the control strategy aligns with existing manufacturing operations to facilitate release and operation of equipment, especially applicable for retrofit type of projects adding to an existing control system.
• Act as system owner for building automation system and standalone PLC based systems responsible for System Administration, maintenance procedures and job plans, spare parts and engineering documentation.
• Responsible for owning and driving to completion Change Controls, CAPAs, and Deviations as applicable to the assigned automation system to ensure reliability and compliance.
• Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as 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 and utility skid equipment.
• Perform and maintain data integrity assessments in accordance with the current Amgen Global Standard procedures and applicable standards.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed