Darric Inselman Email & Phone Number

• Lead Commissioning and Validation documentation efforts for large scale biologics expansion project at MedImmune/AstraZeneca. • Facilitated team projects for Commissioning & Validation for the following systems: WFI, Pure Steam, USP Water, CIP, SIP, Bioreactors, Tanks, Autoclaves, Glasswashers, and CTUs.• Determined scope of work for Commissioning and Qualification protocols and developed testing for multiple systems. • Worked as liaison between global engineering… Show more • Lead Commissioning and Validation documentation efforts for large scale biologics expansion project at MedImmune/AstraZeneca. • Facilitated team projects for Commissioning & Validation for the following systems: WFI, Pure Steam, USP Water, CIP, SIP, Bioreactors, Tanks, Autoclaves, Glasswashers, and CTUs.• Determined scope of work for Commissioning and Qualification protocols and developed testing for multiple systems. • Worked as liaison between global engineering departments and QA/Validation departments to ensure compliance and productivity goals were met.• Developed PQs for Water for Injection (WFI) systems, Pharmaceutical Air, Specialty Gases, Pure Steam systems, and Bioreactors.• Developed Engineering Studies and Sequence of Operations for WFI systems. • Developed Engineering Studies for WFI system and Bioreactor SIP. • Developed and managed equipment resource schedule for PQ activities Show less

• Founded, incorporated, and grew small business• Developed, designed, and produced over 100 unique products.• Organized transition from retail business to wholesale company in 2007• Transitioned from manufacturing to outsourced operations reducing overhead, employees, and lead-time allowing for larger orders, improved margins, and competitive pricing. • Managed customer relations and brought on 75 new sales accounts throughout the United States• Organized Trade Show… Show more • Founded, incorporated, and grew small business• Developed, designed, and produced over 100 unique products.• Organized transition from retail business to wholesale company in 2007• Transitioned from manufacturing to outsourced operations reducing overhead, employees, and lead-time allowing for larger orders, improved margins, and competitive pricing. • Managed customer relations and brought on 75 new sales accounts throughout the United States• Organized Trade Show Exhibitions, Mass Mailing, Email Blasts, and Internet Marketing Campaigns using Google Adwords, and Yahoo Overtures• Managed production scheduling, material supply, employees and contractors• Aggressively sourced new suppliers allowing for a 50% reduction in material cost.• Negotiated Shipping rates with national trucking company to reduce costs 70%• Discontinued operations in 2009. Show less

• Researched mechanical products and constructed taxonomies of product families for online search database of Engineering products.• Lead teams of engineers on database project and trained new team members on database functionality. • Trained on SolidWorks and SolidEdge drafting packages.

• Developed validation protocols at premier pharmaceutical production facility for Cycle Development, IQ’s, OQ’s, & PQ’s• Executed protocol testing procedures for clean steam generation systems, autoclaves, freezers and media production areas.• Conducted data analysis, results interpretation, and developed final reports. • Presented results and reports to clients, and made recommendations for process improvements to ensure compliance.• Provided technical training to… Show more • Developed validation protocols at premier pharmaceutical production facility for Cycle Development, IQ’s, OQ’s, & PQ’s• Executed protocol testing procedures for clean steam generation systems, autoclaves, freezers and media production areas.• Conducted data analysis, results interpretation, and developed final reports. • Presented results and reports to clients, and made recommendations for process improvements to ensure compliance.• Provided technical training to validation specialists, and client staff on equipment functionality, testing procedures, and regulatory requirements.• Acted as subject mater expert for company and client on cGMPs, BS ENs, and PDA Technical Monographs• Organized client entertainment, event planning, networking, and sales discussions that lead to additional projects and headcount on client site. Show less

•Managed maintenance of plant mechanical systems including steam, hot water, cold DI water, ozone purification systems, mixing vessels, product transfer piping, filling and packaging lines.•Organized internal maintenance personnel and managed the hiring of contractors for repairs and plant improvements.•Oversaw the successful installation of Ozone Water Purification system to eliminate plant wide Biofilm water contamination threat. •Managed water purification operations for… Show more •Managed maintenance of plant mechanical systems including steam, hot water, cold DI water, ozone purification systems, mixing vessels, product transfer piping, filling and packaging lines.•Organized internal maintenance personnel and managed the hiring of contractors for repairs and plant improvements.•Oversaw the successful installation of Ozone Water Purification system to eliminate plant wide Biofilm water contamination threat. •Managed water purification operations for elimination of mature biofilms utilizing multiple new technologies including Ozone, ultraviolet light, chemical treatment, filtration, and piping redesign. •Implemented a bacterial level monitoring system through water sampling, including continuous data collection and analysis with cooperation of facilities laboratory.•Monitoring and plant wide improvements lead to securing Proctor and Gamble, Este Lauder, and Aveda as customers. •Selected new aluminum tube filling and packaging line •Selected compounding pilot mixing vessel for assisting of batch scale up from laboratory test batching to full scale production. •Facilitated process design & improvements for new and existing products •Conducted Factory Acceptance Testing, IQ, OQ, PQ, writing of SOP’s and training manuals for newly installed systems.•Conducted cGMP Training of management staff and plant personnel•Created and facilitated “New Product Introduction Team” meetings to ensure successful and timely launch of new products by all plant departments.•Conducted product failure analysis, created corrective & preventive action documentation, procedure writing, organization and facilitation of plant audits to meet customer audit criteria. •Served as technical customer relations specialist assisting in building customer confidence. Show less

•Production supervision (62 Operators), goal setting, team leading, personnel management, conflict resolution, quality control, training.•Established preventative maintenance system for operator staff to improve equipment performance and throughput. •Implemented plant improvements to reduce scrap, lower WIP, and increase yields.

Certificate Program, Six Sigma - Lean Master Black Belt

Bs, Mechanical Engineering