Work with the core team to develop, complete and implement a contamination control plan for mobile cleanrooms.
Develop and complete trace matrix to determine which internal procedures can be leveraged from current site procedures and which need development for the contamination control plan.
Perform gap analysis between leveraged site procedures and ISO 14698, BS EN 17141, and ISO 14644-1-4.
Work with the core team and management in defining gaps and implementing resolution plans.
Work with the core team to develop a cleaning and sanitization program for the mobile cleanrooms per ISO 14644-13.
Work with the core team to develop a material management program for the mobile cleanrooms.
Work with the core team to develop a growing program for the mobile cleanrooms.
Work with the core team to develop and complete a risk assessment for the mobile cleanrooms.
Revise and/or draft and implement procedures applicable to the contamination control plan for the mobile cleanrooms.
Work with the core team to develop, complete and implement a contamination control plan for the current and new internal cleanrooms.
Work with the core team to adapt the current cleaning and sanitization program for the new internal cleanrooms per ISO 14644-13.
Revise and/or draft and implement procedures applicable to the contamination control plan for the new internal cleanrooms.
Report into the core team providing status updates for projects.
Manage timely & consistent communications with Project Management leadership.
Additional Duties
Completing onboarding, including:
completion of training for cleanroom expansion activities.
Integrate with core team and site representatives.
Knowledge of site specific procedures relevant to manufacturing, environmental monitoring and contamination control.
Begin development of contamination control plan.
Complete trace matrix and gap assessments.
Begin development of cleaning/sanitization, gowning and material management programs.
Continue work with the core team for the completion of new and developed procedures.
Complete risk assessment and EM sampling program.
Continue work with the core team to support the start up of manufacturing of mobile cleanrooms and new internal cleanrooms.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
Medical Equipment Manufacturing
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