E2E Engineering SME

For our client, a leading CDMO in the pharmaceutical industry, we are looking for an experienced Engineering and Maintenance Subject Matter Expert to improve and standardize maintenance processes across the equipment lifecycle.

You will combine technical maintenance expertise with practical process improvement, working closely with Engineering, Maintenance, Operations, Quality and Operational Excellence. The assignment covers process assessment, workshop facilitation, documentation and implementation, with SAP PM supporting the operational workflows.

Your responsibilities

• Assess existing engineering and maintenance processes across the asset lifecycle, from planning, procurement and qualification through operational maintenance.
• Lead three cross-functional workshops covering As-Is process mapping, gap analysis and To-Be process alignment.
• Identify inefficiencies, unclear responsibilities and compliance gaps, and develop practical improvement measures.
• Standardize preventive maintenance, corrective maintenance and calibration workflows.
• Define responsibilities and interfaces between Engineering, Maintenance, Operations, Quality and SAP PM.
• Create process maps, flowcharts and RACI matrices, and draft or update SOPs and work instructions.
• Integrate GMP documentation, traceability and data integrity requirements into the redesigned processes.
• Support implementation and adoption of agreed improvements together with Operational Excellence.
• Collaborate with IT and CSV specialists where processes interface with computerized systems.

Your profile

• Degree or technical qualification in Engineering, Maintenance, Industrial Engineering or a related field.
• Several years of experience in maintenance, engineering or asset lifecycle management within pharmaceutical, biotechnology or CDMO manufacturing.
• Strong understanding of preventive and corrective maintenance, calibration and equipment lifecycle processes.
• Proven experience improving operational processes, including process mapping, gap analysis and implementation.
• Practical SAP PM knowledge, including its use in maintenance operations, equipment master data and maintenance records.
• Experience facilitating cross-functional workshops and translating findings into clear, actionable deliverables.
• Ability to develop SOPs, work instructions, process flowcharts and responsibility matrices.
• Solid understanding of GMP requirements and data integrity; familiarity with qualification, validation interfaces and GAMP 5 is an advantage.
• Fluent German and professional English.
• Availability to work onsite in the Basel area 2–3 days per week.

You bring a structured, independent and collaborative approach, with the ability to turn complex workflows into practical processes that teams can use in daily operations.

The focus is on maintenance process excellence and hands-on implementation. SAP PM configuration and CSV execution are outside the scope of this assignment.