Senior Process Engineer (Cleaning & Sterilization)

Quick Facts

• Role: Senior Engineer – Cleaning & Sterilization Lead

• Focus: Drug Substance Cleaning & Sterilization (CIP, SIP, caustic cleaning)

• Initial priority: ANC2 Capital Project

Description

Provide engineering leadership and technical expertise for planning, design, construction, start-up, and operational support of Drug Substance Cleaning & Sterilization systems. Lead CIP/SIP and related cleaning and sterilization capabilities, starting with the Amgen North Carolina 2 (ANC2) Capital Project and then supporting the global network with troubleshooting, continuous improvement, and future capital initiatives.

Responsibilities

• Serve as CIP/SIP Engineering lead for the ANC2 DS Facility Project

• Own the successful design, construction, commissioning, and start-up of the facility cleaning and sterilization scope

• Cover key systems including three CIP skids and associated cleaning circuits, plant-wide SIP operations, downstream caustic cleaning, and glass wash/autoclave systems

• Support design of cleaning & sterilization equipment for capital projects across the network

• Provide CIP/SIP expertise to the Operations network and partners

• Troubleshoot and remediate emergent events to prevent recurrence across the network

• Translate business needs into engineering technology solutions

• Publish and maintain engineering standards and specifications

• Review performance data and recommend improvements

• Facilitate business-case development for project proposals

• Collaborate with design teams and external consultants on engineering development plans, standards, and equipment selection

• Investigate and deploy new technology; optimize total equipment life cycle

• Advance digitalization tools for cleaning-system optimization and other engineering efforts

• Support development of maintenance standards and techniques

• Travel up to 30%

Requirements

• High school diploma/GED and 10 years of engineering experience OR Associate’s degree and 8 years OR Bachelor’s degree and 4 years OR Master’s degree and 2 years OR Doctorate degree

• Professional registration such as a Professional Engineer (PE) license or equivalent (preferred) or on route to it

• Certified Energy Manager (CEM) qualification (advantage)

• Familiarity and/or experience working in a regulated environment (pharmaceutical or biotechnology industries, or electronics) (preferred)

• Strong communication skills (written and oral)

Benefits

• Competitive base salary and eligibility-based Total Rewards Plan

• Comprehensive employee benefits including retirement and savings plan with generous company contributions, and medical/dental/vision coverage

• Life and disability insurance and flexible spending accounts

• Discretionary annual bonus (or sales incentive for field sales roles)

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible (based on work location type)