Sebastian Hirth

Project Manager & Lead for CAPEX project volume ≥ 0.5 Million €, including RFQ, design, vendor auditing & scoring, DQ, FAT, SAT, COM, IQ/OQ, PQ phase. Implementation of Engineering Optimization, New Equipment, Continuous Improvement Projects & expansion activities related to Clean Utilities, (Clean Room, Monitoring) Infrastructure & Facilities. Deviation, CAPA, Change, SOP & Life Cycle Management. Certified Major Investigator for deviation investigations. SME & support function during FDA & GHA Audits.

Implementation of Engineering Optimization, New Equipment, Continuous Improvement Projects & expansion activities related to Clean Utilities, (Clean Room, Monitoring) Infrastructure & Facilities. Project Manager & Lead for CAPEX project volume ≥ 0.5 Million €, including RFQ, design, vendor auditing & scoring, DQ, FAT, SAT, COM, IQ/OQ, PQ phase. Deviation, CAPA, Change, SOP & Life Cycle Management. Certified Major Investigator for deviation investigations. SME & support function during FDA & GHA Audits.

Work on cross-functional project teams, providing engineering support for Clean Utilities, Infrastructure & Facilities, Automation and Calibration & Maintenance departments. Maintaining ongoing compliance with Plant Engineering group for deviations, CAPAs & Change Controls. Collaboration with peers in the continuous improvement of technical infrastructure. Site Environmental Monitoring System SME. Maintenance & auditing of engineering documentation (e.g. PFDs, P&IDs, URSs, RFQs, IQ, OQ, SOPs).

On-Site support for customer projects: FDA Audit Support Deviation Management CAPA / Change Management Project Management for SOP Revisions Department specific compliance tracking Support of various customer related projects Performance of QNAs, MNAs and SRAs Performance of Risk Analyses, Like-for-Like and Product Impact Assessments Commissioning and maintenance support Realization of system improvements Review of validation protocols Installation qualification support