Sr. Engineer

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Sr. Engineer

Live

What you will do

Let’s do this. Let’s change the world. In this vital role Amgen’s Manufacturing Clinical Supply (MCS) Facilities and Engineering organization is seeking a highly motivated Senior Engineer to provide project engineering support to Drug Product, DP Assembly, and Synthetics areas. The candidate will play a key role in implementing new and modified equipment, facilities, and utilities and integrating new technologies to advance Amgen's clinical and commercial products' supply.

Responsibilities:

• Provide technical leadership using engineering principles and drive forward projects varying from functional area projects focused on improving process equipment/utilities/facilities to large, complex capital projects to integrate new drug product manufacturing and device assembly and packaging technologies into clinical/commercial facilities. Leverage engineering expertise within the company and industry best practices, ensure compliance with pertinent environmental health and safety practices, and align with evolving regulatory expectations and internal quality standards to implement new equipment and/or equipment/utility/facility modifications.
• Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects (<$300K) such as equipment/utility/facility modifications to large capital projects (>$3M) that include facility construction and new equipment integration into clinical/commercial facilities. This includes ensuring effective communication flow between cross-functional teams (e.g. F&E, Manufacturing, Quality, Project controls, project management, EHSS) and functional management, leading the selection of contractors for C&Q execution, managing their training and performance, C&Q deliverables and schedule to meet project timelines, and ensuring compliance with Amgen safety, C&Q and Quality standards.
• Manage the portfolio of improvement/innovation projects within the F&E drug product engineering group using strategic approaches and resource prioritization.
• Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits.
• Up to 10% domestic/international travel

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications:

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Engineering and/or Operations experience

Or

Bachelor’s degree and 4 years of Engineering and/or Operations experience

Or

Associate’s degree and 8 years of Engineering and/or Operations experience

Or

High school diploma / GED and 10 years of Engineering and/or Operations experience

Preferred Qualifications:

• Master’s degree in Chemical or Mechanical Engineering
• 6+ years of relevant work experience with 3+ years experience in Biopharmaceutical operations/manufacturing environment
• Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
• Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as continuous fill lines (washer, tunnel, filler, isolator, cappers and lyophilization), lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean-in-place (CIP) systems, washers, clean steam, water for injection, etc.
• Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
• Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
• Understanding