Operations Engineer Manufacturing Solids

Project overview

Operations Engineer Manufacturing Solids

Responsibilities

Qualification:

Framework Data:

• Analysis of complex technical problems on process equipment, and development and expert evaluation of solution options for process optimization
• Expert analysis of technical deviations, execution of root cause analyses, and development and evaluation of CAPA recommendations
• Consultation on the planning and expert design of CAPA measures and change control concepts
• Analysis of existing SOPs and GMP documentation, and development of optimization proposals and GMP-compliant documentation concepts
• Risk assessments (e.g., FMEA) and development of expert recommendations for action to minimize risk
• Conception of expert training materials and transfer of expert knowledge on GMP-relevant issues within defined project mandates
• Consultation of department management on GMP-relevant optimization projects and expert support of improvement initiatives
• Expert support of the commissioning of a tablet press by providing GMP and engineering expertise, as well as analysis and evaluation of technical issues in the project context
• Completed engineering degree or comparable qualification desirable
• Min. 5 years of experience in a GMP-regulated environment required
• Min. 3 years of experience in tablet manufacturing required
• Sound knowledge of deviation and CAPA management as well as GMP regulations (EU-GMP) required
• Structured, independent, and solution-oriented way of working

Project details

15.11.2026

4 months

Utilization: 5 days a week

Germany

• Start: ASAP
• Duration: 4 months
• Remote: remote
• Location: Germany, DE
• Languages: German