Technical Lead Evarrest EXOPS GROW
• Process Engineer for Evarrest and Externally manufactured Surgiflo
• Technical support to functions and partners that lead workstream for the following programs:
o Grifols implementation and LCM - the CMO for Lyo Thrombin from the fractionation stage up to final product
o Patheon LCM - the CMO of Lyo Thrombin from the thawing/lyo stage up to final product
o Ness Ziona BB and LCM – E2E Evarrest manufacturing (from DS pooling to e-beam irradiation)
Good technical writing skills.
Experience with lyophilization.
Background in coordination of projects' execution.
Ability to facilitate resolution of technical and operational problems.
Ability to manage the investigation and timely resolution of issues arising from customer complaints.
Review and approve technical documentation for process and design validations to verify compliance to technical specifications and standards.
Communication with internal and external partners to coordinate and execute project plans.
Assign tasks according to projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.
Support cross-functional project teams to facilitate the transfer of new production processes and execute implementation activities to support product launch.
Ability to understand statistical data and to apply statistical analysis techniques, to improve related processes, as a Six Sigma Belt.
Responsible for developing and managing risk mitigation. Can assist in product risk analysis in evaluating potential crises.
Understands how process parameters affect assembly/equipment outputs. Provides technical assistance to others. Can develop strategy per crisis for best solution given multiple options. Makes technical recommendations based on results and previous work.
Capable to anticipate problems based on a brief statistical analysis.
Ability to issue and manage Change control projects.
Location: נס ציונה