Manage a team of engineers to support the process engineering and validation needs of a multi-product biopharma facility.

Project Manager/Site LeadFebruary 2016 to present• Managed multiple (10+) projects at one time with a total budget of $1.1 MM and 5-10 total resources.• Championed Validation Standards to integrate Quality Management System for LAF hood qualification and CTU qualification.• Authored Validation Plans for facility modification, qualification of areas in accordance with ISO-14644-1, warehouse establishment, and CTU validation methodology remediation.• Reviewed and/or approved requirements risk assessments, URS, IQ/OQ/PQ protocols and reports, and trace matrices.Sr. EngineerSeptember 2015 to February 2016• Completed qualification of 15+ FUSE including Single Use Tangential Flow Filtration skids, Single-Use Bioreactors, impulse mixers, resin slurry tanks, chromatography columns and pack stations.• Authored IQ/OQ protocols and reports, system impact assessments, equipment qualification assessments, and system requirement specifications.Project Manager/Engineer II• Led a team of 5 to drive 50 total qualifications, including a total of 3 Autoclave PQs and 2 Bioreactor SIP PQs, to closure in 2 months.• Scheduled qualification of 75+ FUSE, both restart and new process equipment, during Phase 3 and Phase 4. Reported progress to senior management daily.• Reviewed and approved protocols and reports for Validation. Provided guidance to team members on GMP compliance, validation principles, and root cause methodology to complete qualifications.• Completed 30+ qualifications of utilities, controlled temperature units (CTUs), laboratory equipment, and new processing equipment to closure (in Validation Engineer role).• Led utilities qualification of compressed gases and water systems across multiple buildings. Completed trouble shooting and exception resolution.• Utilized Kaye Validator, Sensitech, and AirCheck equipment to complete executions.

Responsible for real time manufacturing support in live virus vaccines.• Led cross-functional team with Laboratory Operations, Quality Standards, Quality Assurance, Validation, Master Data, Planning, Vaccine Operations and Quality Operations. • Successfully implemented pre-filtration bioburden sampling and redundant filtration for six products on the floor in the MMR franchise. • Developed and led Change Initiator training for changes related to Quality Standards and Lab Ops.• Updated multiple SOPs for Corrective Action/Preventative Action (CAPAs) and routine updates.• Developed and implemented new cleaning method for tanks used during manufacturing in order to reduce deviations and downtime.• Initiated review and approval of Master Batch Records (13 in total for MMR) for Technology.• Updated egg cutter cleaning and sterilization procedure to standardize among technicians and to include current standards.• Provided first-line manufacturing support including issuing Master Batch Records to the floor and stamping in changes. • Supported the manufacturing floor in person during key processes.

Responsible for Special Projects, Deviation Management and Direct Support for real time manufacturing.• Investigated increased protease cutting of the Hepatitis B surface antigen using Lean Six Sigma methodology. The protease cutting caused a batch discard (loss of $2 million) and after correcting the root causes, no further failures for this analytical test have occurred. • Led cleaning development activities on chromatography column slurry tank, including protocol design, approval and sample submission. Reduced resources to verify cleanliness of equipment, saving120 hours of downtime per year.• Participated in automation valve map and P&ID walk downs and make recommendations based on technical considerations. Recombivax and Alum sterile boundary assurance capital project team member, focusing on process history data.• Analyzed historical process data to determine Comparability Alert Levels and documented the new CALs to transfer Alum process to new facility, doubling capacity limits.• Investigated anomalous production events, including residue events and pump leaks.• Supervised two interns to develop a Proactive Process Monitoring system.

Prototype development for spiral wound heat resistant gaskets.

Prototype development for microwavable curing of grinding wheels.