Senior Process Engineer

Do you want to be a driving force in a rapidly expanding environment, making a tangible difference in the process?

Our Client a leading Pharmaceutical Manufacturing company is looking for a Senior Process Engineer

Tasks

• Lead development, qualification, and optimization of aseptic and sterile manufacturing processes for long acting injectables.
• Define, maintain, and document critical process parameters (CPPs) and critical quality attributes (CQAs)
• Drive process improvements aimed at increasing efficiency, yield, robustness, and scalability.
• Provide technical GMP support, including investigations (deviations), CAPAs, change controls, and batch-related troubleshooting.
• Serve as subject matter expert (SME) for aseptic processing, cleanroom behavior, contamination control, and microbiological risk mitigation.
• Ensure compliance with applicable regulatory and quality standards (EU GMP Annex 1, FDA, ICH).
• Prepare, review, and maintain process documentation such as batch records, protocols, and technical reports.
• Lead process validation activities, including process performance qualification (PPQ).
• Support the selection, commissioning, and qualification of aseptic processing equipment (e.g., isolators, filling machines, sterilization systems).
• Collaborate with CMOs and GMP-manufacturing sites in resolving technical challenges and improving process performance.
• Conduct structured process risk assessments (FMEA, HACCP) and apply statistical/analytical tools.
• Act as technical mentor for junior engineers, technicians, and laboratory staff.
• Partner with Quality Assurance, Formulation Development, and Analytical Chemistry teams to ensure alignment on process readiness and product requirements.

Profile:

• Master's degree in Chemical Engineering, Biotechnology, Pharmacy, Mechanical Engineering, or a related scientific discipline.
• Minimum of 10 years' experience within the pharmaceutical or biotechnology manufacturing industry.
• Strong hands-on experience in GMP-regulated environments, with a focus on aseptic and sterile manufacturing operations.
• Demonstrated expertise in process validation, technology transfer, and equipment qualification activities.
• In-depth knowledge of GMP regulations, EU GMP Annex 1, and industry best practices for aseptic processing.
• Proven experience in sterile filtration, aseptic filling, contamination control, and cleanroom operations.
• Familiarity with process modelling, statistical analysis, and data-driven process improvement methodologies is advantageous.
• Strong analytical and problem-solving capabilities, with a structured and results-oriented approach to decision-making.
• Excellent communication and documentation skills, with the ability to clearly articulate complex technical concepts to diverse stakeholders.

Please email me on or call me at +49 30 726211428