CSL · 1 hour ago
Production Engineer, Fractionation
CSL is a global biotherapeutics leader focused on saving lives through innovative therapies. The Production Engineer provides frontline engineering support to pharmaceutical manufacturing operations, ensuring equipment reliability and compliance while collaborating with various teams to enhance asset management and continuous improvement initiatives.
BiotechnologyHealth CareHealth DiagnosticsMedical
Responsibilities
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
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
Completes any other duties/responsibilities assigned by senior management
Qualification
Required
Bachelor's degree in engineering (Chemical, Mechanical, Electrical) 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
Preferred
related field preferred
Knowledge of Six Sigma/Lean principles is a plus
Company
CSL
CSL develops innovative biotherapies and influenza vaccines that save lives, and help people with life-threatening medical conditions.
Funding
Current Stage
Public CompanyTotal Funding
$111M2013-12-20Acquired
2004-02-06Post Ipo Equity· $111M
1994-06-03IPO
Recent News
Pharma Letter
2026-01-03
2025-10-29
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