-Oversaw construction of hygienic and non-hygienic piping, electrical and structural components for 3 UF systems totaling $30M.-Acted as lead CQV engineer over fermentation CIP systems-Developed over 30 CIP routes for fermentation equipment including prep/storage tanks, transfer lines and seed/main fermenters.-Commissioned and troubleshot in process media sterilizer systems.-Commissioned and performed mixing studies on stock solutions prep tank-Performed advanced troubleshooting and assisted in code changes in DeltaV-Project Manager and technical resource on purified water ozination project. The project objective was to update and test the automation to allow for ozinated water to pulse through POU drops to the clients systems during the weekly sanitizations.-Project Manager over industrial water piping project in fermentation to install piping to pump seals around the facility-Project Manager over CIP remediation efforts for Purification systems

-Managed mechanical, piping and passivation teams through construction phase of Pfizer’s GTX2 gene therapy facility

-Commissioned purified water systems, acid/base systems and production centrifuges.-Project manager and execution resource overseeing passivation of process piping on the Novo Nordisk DAPI project.

-Execute construction walkdowns on process equipment and utilities-Manage punchlist closeout activities-Coordinate daily activities with commissioning and construction teams

Biogen Solothurn Next Generation Manufacturing (NGM)-FAT lead for Biotech Upstream and Downstream Process equipment

FCC 3.0 Small Scale Support:-Supported the design of a GEA CSC-15 centrifuge. This included reviewing the P&ID, GA’s, BOM’s, and FRS for conformity with Seqirus specifications.-Acted as the main point of communication between Seqirus and GEA weekly meetings. -Responsible for keeping the project delivery date on course by ensuring all critical path deliverables were submitted per the schedule. -Generated equipment bid packages and data sheets for a Harvest Centrifuge, 1000L Single Use Bioreactor, Single Use UF/DF system, and a Chromatography Column.-Created equipment bid tabs and scorecards for project team evaluation.-Submitted purchasing requisition and developed LOA’s for all approved equipment.-Worked with system owners to generate equipment URS’s in Atlas EDMS.-Tracked project spending, accruals, invoices and equipment delivery dates.-Authored the BOD for the FCC 3.0 small scale equipment implementation as well as all SOW’s for piping, electrical, and architectural construction contractors.-Drafted isometric drawings for WFI drops, CS sample cooler, and drain header using Visio. -Sentry CC owner for the installation of a Hitachi Gradient Ultracentrifuge CC40SNX installation.-Worked with engineering firm to spec out a new impeller for a WFI distribution pump in the VPP.-Coordinated necessary lab space renovations with construction vendors in order to accommodate new equipment. -Supported ongoing commissioning when needed for the bulk FCC 3.0 ATF integrations and buffer charging skids-Project Manager of a $555,000 MS&T equipment capital project.-Supported the start-up of the Novartis TD labs in RTP. Responsible for commissioning and overseeing vendor activities on $5M of new equipment and renovations to the site.-Supported site wide decommissioning efforts for different projects when needed.-Performed qualification needs assessments on new GMP equipment.-Fluent with site maintenance and asset management procedures and software.

Clinical Trials Manufacturing Building Engineering Support-Commissioned utilities for new clinical trials manufacturing area. This included process air, clean steam, CO2, instrument air, chilled water, heated hot water, plant steam, and tempered water.-Lead the commissioning efforts for a Bausch & Strobel FAW 1005 Vial Washer, a DHTT2550 Depyrogenation Tunnel, and a KSF1025 Vial Filler. Commissioning included P&ID walkdowns, electrical drawing walkdowns, installation verification, ETOP review, loop tests, alarm test, and functional testing.-Created PM’s, job plans, and calibration PM’s for all CTM equipment which was comprised of a Steris Autoclave and Part Washer, Bausch & Stroebel Vial Fill Line and Syringe Line, SP Scientific Lyophilizer, Eastern Rivers Air Handler Unit, and a Huntair Fan Filter Unit.-Generated required documentation spare parts forms for all CTM equipment. Purchased and assigned spare parts to the correct equipment job plans and PM’s.

Viral Readiness Project-Acted as the owner’s rep and project lead for a $1.2M TD lab redesign and equipment outfitting.-Worked with construction vendors to ensure proper installation of lab gas drops, BAS connections, power supplies, and lab space surface modifications for new equipment.-Supported automation by performing loops check during their commissioning for all equipment integrated with BAS.-Generated sensor risk assessments and PM’s for all equipment.-Commissioned new lab equipment and modifications installed on existing equipment.