Senior Production Engineer, Fractionation

Position Purpose

Position

Purpose:

The Senior Production Engineer provides technical leadership and strategic engineering support to pharmaceutical manufacturing operations, ensuring optimal asset performance, reliability, and compliance throughout the asset lifecycle. This role drives risk-based asset management strategies in alignment with ISO 55000 principles, GMP requirements, and business objectives, while partnering with Production, Maintenance, Quality, and Capital Projects teams.

Reporting Relationships: Role that this position reports to. Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.

• Provide senior-level frontline engineering support for complex equipment issues, leading structured troubleshooting and failure investigations. Such as, but not limited to separation, extraction, purification and filling processes.
• Support fractionation, bulk or fill finish systems including design, operation, and lifecycle management.
• Provide engineering oversight for centrifuges, filter presses, chromatography columns, ultrafiltration and diafiltration, clean-in-place, clean-out-of-place, aseptic transfer technologies, etc.
• Ensure robust GMP practices and contamination control throughout operations.
• Lead Root Cause Analysis (RCA) using recognized methodologies (e.g., FMEA, 5-Why, Fishbone) and ensure effective implementation of CAPAs.
• Define and drive equipment reliability strategies to improve availability, performance, and lifecycle cost.

• Develop, review, and optimize preventive and predictive maintenance strategies based on asset criticality, historical performance, and condition monitoring data.
• Analyze asset health using CMMS data (SAP), including MTBF, MTTR, OEE contributors, and maintenance effectiveness KPIs.
• Champion predictive maintenance technologies and condition-based monitoring to reduce unplanned downtime and asset risk.

• Lead equipment-related changes through formal change control processes and investigations, ensuring GMP compliance, data integrity, and controlled risk.
• Drive continuous improvement initiatives focused on asset reliability, compliance, and operational efficiency, aligned with site and corporate asset management objectives.
• Work to improve equipment reliability as measured by Operational Equipment Effectiveness (OEE).
• Mentor junior engineers and technicians in reliability engineering, asset management principles, and GMP-compliant engineering practices.
• Rotation between value streams.
• Provide technical training on aseptic equipment and best practices.

• Own and govern asset information across the lifecycle, ensuring integrity, traceability, and alignment with ISO 55000 Asset Information Management requirements, including URS, FS/DS, P&IDs, equipment files, and SAP CMMS records.
• Lead asset criticality assessments and risk-based prioritization using failure modes, risk priority numbers (RPNs), and business impact analysis to support maintenance and investment decisions.
• Ensure alignment between asset performance objectives, site asset management plans, and production demand.

• Lead equipment-related projects funded through Capital Expenditure (Cap Ex) or Operational Expenditure (OpEx), including scope definition, business case development, risk assessment, and execution.
• Provide engineering leadership during planned shutdowns, including scope planning, resource coordination, execution oversight, and post-shutdown performance review.
• Support equipment lifecycle decisions, including refurbishment, upgrade, and replacement strategies based on asset condition and business risk.

• Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001 requirements.
• Author, review, and approve SOPs, change controls, deviations, investigations and CAPAs.
• Lead and support qualification and validation activities (IQ/OQ/PQ), ensuring engineering documentation supports regulatory inspections and…