Sr. Process Engineer; Aseptic Operation

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.

Main Responsibilities and Accountabilities:

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 fill/finish operations, including vial, syringe, and cartridge filling lines.

• Support isolator systems, including design, operation, and lifecycle management.

• Provide engineering oversight for vial washer, depyrogenation tunnel, isolator, capper, and aseptic transfer technologies.

• Ensure robust aseptic practices and contamination control throughout filling and finishing 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, 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.

• 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 (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.

6.
Compliance, Quality & Safety

• Ensure engineering activities comply with GMP, EHS, and ISO 55000/55001 requirements.

• Author, review, and approve SOPs/, change controls, deviations, 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:

Education

• Bachelor…