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
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