Senior Production Engineer, Fractionation

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.

1) Process & Equipment Engineering
▪ 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, ultra-filtration 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.

2) Maintenance & Asset Health Monitoring
▪ 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.

3) Change Management & Continuous Improvement
▪ 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.

4) Asset Information & Lifecycle Management (ISO 55000 Alignment)
▪ 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.

5) Projects & Shutdown Support
▪ Lead equipment-related projects funded through Capital Expenditure (CapEx) 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.

6) Compliance, Quality & Safety
▪ 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 audits.
▪ Act as a subject matter expert during internal and external audits related to
equipment, asset management, and reliability.

7) Completes any other duties/responsibilities assigned by senior management

Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the posi