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.

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