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Manufacturing Process Optimization Lead
3 weeks ago
We are seeking a talented individual to lead cross-functional teams in designing, developing, and optimizing manufacturing processes in the life sciences sector. This role involves driving process excellence, ensuring compliance with GMP regulations, and providing technical expertise in areas such as aseptic processing, downstream and upstream processing, filtration, sterilization, fermentation and purification techniques – and/or filling and packaging lines.
Responsibilities:- Lead and manage cross-functional teams in designing, developing, and optimizing manufacturing processes under Senior Project Management supervision.
- Develop and review comprehensive process documentation, including lay-out, P&IDs, standard operating procedures, and batch records.
- Ensure full compliance with GMP regulations, quality standards, and regulatory requirements.
- Provide technical expertise in areas such as aseptic processing, downstream and upstream processing, filtration, sterilization, fermentation and purification techniques – and/or filling and packaging lines.
- Lead or participate in process validation activities to ensure product quality and regulatory compliance.
- Investigate and address deviations, incidents, and quality issues, and recommend corrective and preventive actions.
