Rita Kiefert Email & Phone Number

• Developed standards and streamlined process for repeat projects with a key client.• Project Manager for ISO 7 Cleanroom - oversee manufacturing of custom single-use assemblies• Project Manager for bio-pharmaceutical systems.• Create and manage project schedule for entire life cycle• Procurement of materials and components needed for construction, expedite as needed• Conduct design review and status update meetings with team throughout life of project• Oversee customer factory acceptance testing - resolve any issues and provide final deliverables

Burr Ridge, Il

• Created turnover packages for process validation of pharmaceutical projects.• Coordinate and supervise validation team for all project turnover packages.• Create and align turnover schedules with construction completion dates.• Process all engineering documents, drawings, and project deliverables in accordance with established guidelines and client specific requirements.• Coordinate with engineering staff and customers to ensure successful validation during factory acceptance testing.• Assist with writing of Standard Operating Procedures and Work Instructions.• Technical editing of SOPs, manuals, and all other process/quality documents.• Generate yearly audit plan, conduct internal audits to verify compliance with corporate policies.• Prepare internal audit reports, discuss and finalize audit findings and recommendations with process owners