Production Engineer, Fractionation jobs in United States
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CSL · 15 hours ago

Production Engineer, Fractionation

CSL Behring is a global biotherapeutics leader dedicated to saving lives through innovative therapies. The Production Engineer role focuses on providing engineering support for pharmaceutical manufacturing operations, ensuring equipment reliability and compliance while collaborating with various teams to enhance performance and asset management.

BiotechnologyHealth CareHealth DiagnosticsMedical
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Comp. & Benefits

Responsibilities

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)
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
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
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
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)
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

Qualification

GMP complianceReliability engineeringAsset managementSix SigmaAnalytical problem solvingStakeholder engagementContinuous improvementCommunication

Required

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

Preferred

Bachelor's degree in engineering (Chemical, Mechanical, Electrical) required or related field preferred
Knowledge of Six Sigma/Lean principles is a plus

Company

CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.

Funding

Current Stage
Public Company
Total Funding
$111M
2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO

Leadership Team

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Jeffrey Ball
Chief Sustainability Officer
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Joy Linton
Strategic Advisor
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Company data provided by crunchbase