Production Engineer, Fractionation

CSL Plasma•Kankakee, IL

14d•$78,000 - $98,000

About The Position

The Production Engineer provides frontline engineering support to pharmaceutical manufacturing operations, ensuring equipment reliability, compliance, and performance throughout the asset lifecycle. The role supports troubleshooting, continuous improvement, and asset management activities in alignment with ISO 55000 Asset Management principles and GMP requirements, working closely with Production, Maintenance, Quality, and Engineering teams.

Requirements

Bachelor’s degree in engineering (Chemical, Mechanical, Electrical) required or related field preferred
Minimum of 2 years’ experience in the pharmaceutical, food, or chemical process industry.
Experience in leading day-to-day decisions and personnel management.
Strong knowledge of cGMPs and their application in manufacturing operations
Proven ability to successfully lead projects from start to finish, ensuring they are completed on time, within budget, and meet high standards of quality.
Continuous Improvement & Lean/Six Sigma
Analytical Problem Solving
Stakeholder Engagement & Communication

Nice To Haves

Knowledge of Six Sigma/Lean principles is a plus.

Responsibilities

Equipment Reliability & Operational Support Provide frontline engineering support for manufacturing equipment, responding to equipment-related issues on the production floor to minimize downtime while maintaining GMP compliance. Support troubleshooting of equipment breakdowns using structured problem-solving and reliability engineering methodologies. Participate in Root Cause Analysis (RCA) investigations and support implementation of corrective and preventive actions (CAPAs)
Maintenance & Asset Health Monitoring Analyze asset health data by reviewing corrective maintenance (CM) and preventive maintenance (PM) trends within SAP CMMS. Support identification and implementation of predictive maintenance opportunities based on equipment performance, failure patterns, and risk assessments. Assist in continuous monitoring of equipment reliability metrics such as MTBF, MTTR, and maintenance effectiveness.
Change Management & Continuous Improvement Support equipment-related changes through formal change control processes, ensuring compliance with GMP and site engineering standards. Assist with continuous improvement initiatives focused on improving asset availability, reliability, and lifecycle cost optimization.
Asset Information & Lifecycle Management (ISO 55000 Alignment) Maintain accurate and current asset information, including system specifications, User Requirement Specifications (URS), Functional Specifications (FS), P&IDs, equipment manuals, and SAP CMMS records, in accordance with asset lifecycle management principles. Support the Asset Information Management System by ensuring data integrity, traceability, and version control of engineering documentation. Assist in updating asset criticality assessments and understanding risk priority scores (RPNs) to support risk-based maintenance strategies.
Projects & Shutdown Support Support engineering activities during planned shutdowns, including preparation, execution, and post-shutdown review. Assist in the execution of equipment-related projects funded through Capital Expenditure (CapEx) or Operational Expenditure (OpEx)
Compliance, Quality & Safety Ensure all engineering activities comply with GMP, EHS, and ISO 55000 asset management principles.
Support validation, qualification, and documentation activities where required (IQ/OQ/PQ support), in alignment with pharmaceutical quality systems. Support during internal and external audits related to equipment, asset management, and reliability
Completes any other duties/responsibilities assigned by senior management