Sebastian Hirth

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 sourcing & auditing, DQ, FAT, SAT, COM, IQ/OQ, PQ phase (full life cycle implementation). Deviation, CAPA, Change & SOP Management. Certified major investigator for deviation investigations. SME & support function during FDA & GHA Audits. Compliance with statutory regulations of local authorities.

Project Manager & Lead for CAPEX project volume ≥ 0.5 Million €, including RFQ, design, vendor sourcing & auditing, procurement and commissioning/qualification phase (DQ, FAT, SAT, COM, IQ/OQ, PQ) (full life cycle implementation). Task ownership during implementation of engineering optimization, implementation of new equipment, continuous improvement projects and expansion activities related to Facilities, (Clean Room & Monitoring) Infrastructure & Clean Utilities. FDA & GHA Audit Support: Activities for audit preparation and audit post-processing; support during the Inspection. Maintaining ongoing compliance within Engineering department for Deviation, CAPA, Change & SOP Management. Certified major investigator for deviation investigations of different criticality. SME during Health Authority and Internal Audits and for the site’s environmental monitoring system as well as for various site processes, such as equipment life cycle, ETOP, commissioning & decommissioning process. Preparation and review of project related Building Application documentation & Federal Immission Control Act (BImSchG) relevant documentation for compliance with statutory regulations of local authorities. Correspondence with local authorities. Lead of cross-functional project teams, interaction with vendors & contractors, interfacing function & support during implementation of projects for other departments. Support and performance of assessments for maintenance needs, sensor risk, qualification needs, risk analyses and impact assessments, review and assessment of supplier change notifications. Preparation, maintenance & review of engineering and qualification documentation, including P&IDs, URS, FAT/SAT/commissioning/qualification/validation protocols, periodic review, reports.

Work on cross-functional project teams, providing engineering support for Clean Utilities, Facilities, Automation and Calibration & Maintenance departments. Maintaining ongoing compliance with Plant Engineering group for deviations, CAPAs and Change Controls. Plant Engineering representative throughout the lifeclycle of launching equipment as well as initiation, design, construction, implementation, commissioning and qualification of new equipment. Collaboration with peers in the continuous improvement of technical infrastructure, including engineering standards, practices, specifications, procedures and business processes. Maintenance and auditing of engineering documentation such as PFDs, P&IDs, URSs, Design Specifications, RFQs, IQ, OQ. About Dynavax: "Dynavax GmbH (Dynavax Europe), is the European affiliate of Dynavax Technologies Corporation. For more than 25 years, we have been dedicated to the development and manufacturing of vaccines and biopharmaceuticals. Dynavax Europe is led by an experienced management team with demonstrated expertise in vaccine and biopharmaceutical product development and manufacturing." refer to: http://www.dynavax.com/about-us/dynavax-gmbh/

On-Site support for customer projects with different tasks: FDA Audit Support - Activities for audit preparation and audit post-processing - Support during the Inspection Deviation Management - Lead Investigator for deviations of different criticality - Initiation and execution of action plans - Preparation and review of reports CAPA / Change Management - Initiation, scheduling, execution and closure of corrective / preventive actions and change control Project Management for SOP Revisions - Coordination with other departments and projects - Preparation, revision and review of SOPs - Preparation of exam questions - Establish and maintain a project specific matrix of documentation Department specific compliance tracking for deviations, CAPA and change control Implementation of a site process for asset status labelling and release of assets Support of various customer related projects, including Clean Utilities, Site Access Management, Environmental Monitoring System and Cold Storage Area 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 Alignment of P&IDs with installation plans Installation qualification support - Controlled environment / HVAC system - RO-water / pure steam / compressed air and nitrogen supply About gempex: gempex GmbH is an independent international service enterprise, which is specialized on consulting and execution of GMP-requirements in the Life Science Industry. gempex focuses on consulting and execution services in the field of GMP-Compliance, Commissioning & Qualification, IT-Validation and GMP-Routine. Business activities range from the first analysis to concept planning and realization up to a permanent GMP-support (Expert Leasing). gempex provides high quality services; every acting is affected by quality, reliability and service.