- Evaluate existing customer plant operations, business objectives, and regulatory guidelines to identify operational efficiencies related to time, cost, safety, and quality.- Provide technical expertise and understanding on the qualifications surrounding GMP related cleaning, cleaning process and company certification and validation services.- Ensure operational compliance with FDA, ISO, and any other applicable domestic and international regulations.- Work with internal partners to generate and (or) maintain new site process documentation e.g. Cleaning SOP’s, and any site specific documentation requirements.- Effectively communicate team activities, progress, priorities, to internal partners.

- Revalidation Program Manager- Manage and Develop Regional Staff- SPOC for Clients regarding Staff Scope and Project Deliverables- Assist in Business Development, Change-Orders and Invoicing- Author Testing documentation (Protocols, Reports, SOPs, Work Instructions)- Coordinate and Lead Execution/Sampling activities- Execution of CVAL, CVER and VI requirements- Cleaning Validation Protocol Preparation and Approval- Supporting cleaning documentation revisions- Troubleshooting and Investigations

- Manage Regional Staff and Assigned Regional Projects- SPOC for Clients regarding Staff Scope and Project Deliverables- Assist in Business Development, Change-Orders and Invoicing- Project Manager for Cleaning Validation Optimization project - Perform Cost Benefit Analysis and assess Overall Equipment Effectiveness - Design new and model current process equipment using SolidWorks- Lead DOE for evaluation of new products- Author Testing documentation (Protocols, Reports, SOPs, Work Instructions, etc.)- Coordinate and Lead Execution/Sampling activities- Cleaning Validation Protocol and Batch Record/Recipe Preparation and Approval- Change Control Closure and Validation Master Plan Updates- Revision/Optimization of CIP recipes and Cleaning Assessments- Supporting cleaning documentation revisions- Cleaning Development- Troubleshooting and Investigations

- Draft Batch Record Templates for Serialization documents- Revise Batch Records for assorted products related to Serialization- Revise SOPs related to batch record drafts- Draft Change Controls for MPT revisions- Review Validation reports

- Review and approval of executed batch records- Review and approval of document change requests for batch records and SOPs- Review and approval of NCEs - Develop tools to track movement of NCEs and pre-executed and executed batch records - Perform RFT process improvement utilizing Lean procedures- Perform internal audits and provide feedback for process improvement- Participate in external client audits

-Author protocols for cleaning development, verification and validation-Author SWIs and SOPs for validation execution-Assist with daily execution scheduling -Execution lead -Assist in deviation investigations and close-out-Organize data from site laboratories-Datapack close-out and approval

-Author protocols and reports for cleaning development and validation -Lead personnel scheduling for cleaning validation group-Liaison between laboratories on site and Cleaning Validation-Assist with daily execution scheduling -Execution lead -Assist in deviation investigations and close-out-Implementation of LIMS on site pertaining to Cleaning Validation sample submission-Organize data from site laboratories-Datapack close-out and approval

-Lead Executor for numerous projects on site-Revised SOPs, SWIs, other process and validation procedures-Authored development and validation protocols and reports as well as investigate and close out of deviations-Optimization for Cleaning and Process Validation procedures-Assisted in development of LIMS system on site pertaining to regular use for Cleaning and Process Validation-Sample Coordinator for process and cleaning development and validation samples