• Site lead for Validation, Calibration, Engineering and the OPEX Innovation Team.• Contributing member of the Site Leadership Team and Site Safety Committee.• Development and execution of Installation, Operation, and Performance Qualification (IOPQ) and Commissioning protocols for 15L autoclavable bioreactors, autoclaves, reverse osmosis deionized water system, water pretreatment, walk-in coolers, overhead mixers, cold storage freezers, ultrasonic washers, glass washers, laminar flow hoods, and desiccant air dryers.• Development and execution of validation of the bioreactor cleaning process. • Led team of on-site validation consultants.• Managed the calibration program on-site for calibration off-site, and on-site of all critical equipment.• On-site calibration / verification of temperature dataloggers, thermometers, conductivity meters, peristaltic pumps, roller bottle racks, and mixers.• Led site to 100% participation as on-site manager of the employee giving campaign in 2022.

• Site Lead for Process Validation.• Project management of process validation executions, ensuring material and personnel resources are available for successful completion of qualification runs.• Development of PowerPoint training presentations and conducting training sessions to ensure that personnel involved with protocol executions and QC testing are properly trained on the protocol, relevant procedures and how it relates to FDA guidelines.• Data compilation and analysis of the qualification run results.• QA review of the executed protocols.

• Development of validation installation and operational qualification (IOQ) protocols and summary reports for manufacturing suites, manufacturing equipment, and laboratory equipment for cell and gene therapy, and viral vector clinical and commercial products.• Execution of IOQ protocols for -80C freezers, peristaltic pumps, inspection stations, and manufacturing suites.• Testing of the equipment continuous monitoring systems to verify that the equipment are being monitored and controlled appropriately to maintain a validated state.• Setup and operation of Ellab E-Val Pro.• Investigation and determination of root cause of unplanned deviations.

• Management and implementation of engineering projects; initial design, procurement, implementation, and close-out.• Development of engineering test plans for equipment installations.• Design and implementation of Change Controls, CAPAs (corrective action / preventative action) and engineering test plans. • Development of Quality Risk Management (QRM) Assessments and reports using formal QRM analysis tools.• Investigation of deviations root cause analysis and risk assessments.• Determination of calibration ranges and tolerances for instrumentation based on user requirement specifications (URS) and instrument specifications.• Visual inspection and verification of equipment in-field.• Review and approval of turn-over-packages (TOPs) material test reports (MTRs), weld logs, passivation, cleaned-for-oxygen and argon certification, certificates of conformance, isometric drawings, piping and instrumentation diagrams (P&IDs), etc.• Review and approval of environmental monitoring chemical and microbiology test results, calibration records and facilities work orders.• P&ID walk-downs, redlines and slope verification.• Implementation of corrective action / preventative action (CAPAs); often related to change controls.• Revised SOPs to update procedures impacted by engineering changes.• Collaboration with cross-functional groups and regular reporting of progress to stakeholders.• Procurement of components, materials, equipment, contractors, fabricators and technicians. • Systems and equipment include pharmaceutical air, WFI generation, storage and distribution, clean steam facilities, UF/DF skids, bioreactors and other stainless steel vessels, various types of piping, various types of valves, vapor compression stills, single-use bioreactors (SUBs), filter housings, various types of pumps, etc.• Instrumentation installation; weight transmitters, variable frequency drives, flow transmitters, level transmitters and switches, pressure transmitters and indicators.

• Design of qualification and validation protocols for IQ, OQ, PQ, CIP, SIP, clean hold and continuing validation.• Execution of CIP, SIP, clean hold and continuing validation protocols for upstream and downstream unit operations, e.g. bioreactors, chromatography skids, centrifuges, UF/DF skids, depth filters, UF/DF tanks, protein A pool tanks, purification tanks, media tanks, buffer tanks, and transfer lines.• Investigation of deviations and authorship of deviation reports for protocol discrepancies.• Scheduling validation activities for IQ, OQ, PQ, CIP, SIP, clean hold and continuing validation.• Execution of IQ, OQ and commissioning for the start-up of new manufacturing areas for upstream and downstream biopharmaceutical processing equipment.

• Performance of third party audit of the WFI, purified water, and HVAC PQ studies; gap analysis of qualifications and recommendations for regulatory compliance.• Execution of FATs for media prep skid, buffer prep skid and clarification filters, including CIP sprayball coverage verification, weld verification, welder qualification verification, BOM/components verification, system walk-downs, system drainability testing, URS/FRS verification and ETOP review.• Troubleshooting CIP coverage testing and system drainability testing issues.• Performance of design qualifications for manufacturing equipment. • Performance of equipment component criticality assessments (CCAs) for process air, parts washers, autoclaves, bioreactors, centrifuges, UF/DFs, buffer skids, chromatography columns, clarification filters, WFI generation and depth filters.

• Performance of third party audit of the WFI, purified water, and HVAC PQ studies; gap analysis of qualifications and recommendations for regulatory compliance.• Execution of FATs for media prep skid, buffer prep skid and clarification filters, including CIP sprayball coverage verification, weld verification, welder qualification verification, BOM/components verification, system walk-downs, system drainability testing, URS/FRS verification and ETOP review.• Troubleshooting CIP coverage testing and system drainability testing issues.• Performance of design qualifications for manufacturing equipment. • Performance of equipment component criticality assessments (CCAs) for process air, parts washers, autoclaves, bioreactors, centrifuges, UF/DFs, buffer skids, chromatography columns, clarification filters, WFI generation and depth filters.

• Development and design of validation protocols and qualifications for thermal mapping, IQ/OQ, SIP, CIP, WFI, purified water, and steam quality.• Execution of CIP, SIP, IQ/OQ on biopharmaceutical equipment including bioreactors, feed vessels, buffer vessels, product vessels, filter stations, transfer lines, clean steam, heat exchangers, controllers, autoclaves, incubators and cold storage rooms.• Performance of engineering runs to troubleshoot CIP cycle issues.• Development of SOPs for consistent CIP cycles.• Investigation of qualification deviations, including impact assessment, and corrective actions.

• Implementation of engineering projects to reduce manufacturing costs of steam turbines and electrical generators. • Assessment of required inputs and outputs in electrical enclosures, and determination of functionally equivalent parts.• Assessment of component specifications for determination of compatibility in generators, and control systems.• Determination of functionality requirements for the development of new products.

Summer Contract