Experience

Sancilio & company

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Specialist

  • Mar 2014 - Present

  Responsible for validation documentation activities in a cGMP regulated pharmaceutical manufacturing environment. Prepare validation documents to support new product launches and any changes to existing validated manufacturing processes for regulated products. Write Cleaning and Process Validation protocols, process flow diagrams, test cases, and standard operating procedures. Conduct validation or qualification tests of new or existing processes, equipment, or software in… Show more Responsible for validation documentation activities in a cGMP regulated pharmaceutical manufacturing environment. Prepare validation documents to support new product launches and any changes to existing validated manufacturing processes for regulated products. Write Cleaning and Process Validation protocols, process flow diagrams, test cases, and standard operating procedures. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and procedures. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root cause of production problems. Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, and protocols. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols. Create, populate, or maintain databases for tracking validation activities, test results, or validated systems. Identify deviations from established product or process standards and provide recommendations for resolving deviations. Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies. Other duties as assigned. Show less Responsible for validation documentation activities in a cGMP regulated pharmaceutical manufacturing environment. Prepare validation documents to support new product launches and any changes to existing validated manufacturing processes for regulated products. Write Cleaning and Process Validation protocols, process flow diagrams, test cases, and standard operating procedures. Conduct validation or qualification tests of new or existing processes, equipment, or software in… Show more Responsible for validation documentation activities in a cGMP regulated pharmaceutical manufacturing environment. Prepare validation documents to support new product launches and any changes to existing validated manufacturing processes for regulated products. Write Cleaning and Process Validation protocols, process flow diagrams, test cases, and standard operating procedures. Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and procedures. Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root cause of production problems. Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, and protocols. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols. Create, populate, or maintain databases for tracking validation activities, test results, or validated systems. Identify deviations from established product or process standards and provide recommendations for resolving deviations. Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies. Other duties as assigned. Show less



AT&T / Accenture / Avanade

• IT Consultant Microsoft Exchange and Windows Administor

  • Jul 2007 - Mar 2010

  Remote Enterprise Microsoft Exchange 2000/2003 admin. Remote Enterprise Microsoft Windows 2000/2003 admin. Application support. Remote Enterprise Microsoft Exchange 2000/2003 admin. Remote Enterprise Microsoft Windows 2000/2003 admin. Application support.



Honeywell Technology Solutions, Inc.

• IT Consultant Microsoft Exchange and Windows Administration

  • Jun 2006 - Apr 2007

  Microsoft Exchange and Windows admin for NASA email servers.

• IT Consultant Microsoft Exchange and Windows Administration

  • Aug 2005 - Jun 2006

  Remote Microsoft Exchange and Windows Administration.



IBM / Lucent Technologies

• IT Consultant Microsoft Exchange Administration

  • Aug 2001 - Apr 2005

  Tier 2 Team Lead - supervised and coordinated a 3 shift Tier 2 help desk operation for Lucent world wide enterprise Exchange e-mail system. Microsoft Exchange and Windows Administration.

• IT Consultant Microsoft Exchange and Windows Administrator.

  • Oct 1998 - Aug 2001

  Remote Exchange and Windows Administration.