Process Engineer II - Equipment Engineering

Kite Pharma•Frederick, MD

1d•$99,705 - $129,030•Onsite

About The Position

This role will support manufacturing, quality control, and facility equipment systems used in the production of life-saving cell therapy products. The successful candidate will work closely with Manufacturing, Quality, Validation, Maintenance, Supply Chain, and external vendors to ensure equipment reliability, compliance, and operational excellence within a GMP manufacturing environment.

Requirements

Bachelor's degree in Engineering, such as Chemical Engineering, Mechanical Engineering, Bioengineering or similar.
3–5 years of engineering experience in biotechnology, pharmaceutical, medical device, or related regulated industry.

Nice To Haves

Familiarity with GMP manufacturing environments
Strong analytical and problem-solving skills
Effective written and verbal communication skills
Ability to work within cross-functional teams
Experience with equipment maintenance, troubleshooting, or validation activities
Experience with one or more asset types: cell therapy manufacturing equipment, automated manufacturing platforms, laboratory instrumentation, cryogenic storage systems, filter integrity testing systems.

Responsibilities

Support operation and lifecycle management of manufacturing, laboratory, and facility equipment.
Serve as Technical Owner of equipment within the Enterprise Asset Management System for repairs, maintenance, and other asset lifecycle requests.
Serve as an engineering resource for equipment investigations, troubleshooting, and root cause analysis.
Analyze equipment failures and performance trends to identify recurring issues and reliability opportunities.
Support implementation of corrective and preventive actions (CAPAs) and change controls.
Assist with specification, procurement, installation, commissioning, and qualification of new equipment.
Support equipment reliability initiatives including maintenance optimization and spare parts strategies.
Author and review engineering documentation including: Engineering assessments, Technical reports, Change controls
Support vendor management activities and execution of service projects.
Participate in capital projects and facility improvement initiatives.
Partner with Maintenance to improve work order effectiveness and equipment performance metrics.
Utilize equipment history, maintenance records, and performance data to support reliability decision-making.
Collaborate with cross-functional teams to improve equipment reliability, compliance, capacity, and operational efficiency.
Support regulatory inspections and internal audits as required.
Contribute to continuous improvement initiatives focused on safety, quality, compliance, and cost reduction.