CQV Engineer with Pharmaceutical Industry Experience

Commissioning execution, post-test execution peer review and approval. Installation Qualification execution and approval. Includes release for OQ. Operational Qualification execution and approval. Includes release for PQ / Handover. Shall be able to work / support another C&Q activity if deemed necessary. Carry out shift work, where required. Use of Siemens PCS and MES system. Role and responsibilities Self-manage CQ execution activities with respect to the relevant systems. Function as a key member of the CVQ Team. Maintain control over the activities and schedule with respect to the relevant systems. Coordination and communication with other resources in CVQ and other Depts. Adherence to project procedures/requirements with respect to Health/Safety/Environmental, Quality (including GDP/GMP), CQ (including IQ, OQ, Commissioning). Liaise closely with the relevant vendors/providers/contractors, project Automation representatives to ensure integration of activities and schedules with respect to the relevant systems. Actively participate in the development and delivery of deliverables with respect to the relevant systems. Report and aid in the resolution of project issues, including maintaining the punches and a deviations. Assist in assessing project risk and evaluating the effectiveness of mitigation strategies applied. Prioritize and execute tasks in a fast-paced environment. 06/2022 – 12/2022 Engineer CQV lead DSP MERCK SERONO SA - 1804 Corsier-sur-Vevey Lead, manage and execute CQV activities for process systems, including: • Lead a cross-functional CQV team which includes an automation engineer, process/project engineer and end-users • Manage equipment vendors during execution of Site Acceptance Testing with support from CQV team • Execute protocols for commissioning, IQ and OQ with support from CQV team • Ensure all vendor documentation is complete and correct • Ensure each process system is functioning according to the approved specifications • Verify process equipment functionality using the process control system (Delta-V)o Testing of CMs, EMs, phases, alarms, interlocks, etc. • Identify, investigate and close any protocol deviations • Review and approve CQV protocols and final reports • Ensure the CQV team is following all safety protocols (LOTO, start-up plans, etc.) 09/2017 - 05/2022 Manufacturing associate IV Biogen Switzerland AG - 4542 Luterbach Luterbach, Solothurn, Switzerland. Commissioning, validation activities, from scratch, using Kneat software. Knowledge gained, skills equivalent as a CQV engineer in the last 4 years. Use of DeltaV and Syncade. Valve functionality, EM, phase, OP, UP, recipe testing. Automation document FDS, hardwire and software interlock, control, and review. Energization of the systems, WFI, plant steam, clean steam, glycol. Commissioning test protocol, execution, and review. FAT, SAT, P&ID walkdown, Safety walkdowns (trained on job hazards authorization), calibration report verification, pressure test, Palamatic lifters installation supervision. Motor rotation, pressure hold, vessel characterization, resonance test, inline dilution, hold up volume, concentration mixing, dynamic pressure, CIP, E-stop testing, dynamic transfer, SIP. Areas in charge, media prep, Buffer prep and Buffer hold, Purification Skids in purification: chromatography column, MAB, anion exchange and hydrophobic interaction. Viral filtration skid Ultra-filtration, Dia-filtration, and single pass tangential filtration. Dispensing and formulation. Column packing SME. Trained on autoPall skid. Laboratory process knowledge. Lims access, ELN management, labware. Current training measurements method: proteins concentration (SOLOVPE), LAL (endotoxins), Bioburden, pH and conductivity, TOC Change control documents as initiator. Back-up supervisor POC, point of contact. 05/2017 - 09/2017 production technician DSP expert Shire Pharmaceuticals - Neuchatel investigation. technical expertise manual access on the production skids participation continuous improvement projects rational editing, event, memo technician coaching on the floor back-up team leader 6 months on 'IDbox', implementation of various projects 'savings' and 'cost reduction' 06/2016 - 05/2017 Production Technician DSP Shire pharmaceutical - Neuchâtel Suisse chromatography and buffer technician participation projet FAT / IOQ/ PQ/DV , Validation protocol redaction validation CIP/SIP. 07/2015 - 05/2016 production technician DSP baxalta - neuchatel chromatography technician Quality documents change training 10/2009 - 06/2015 technicien de production baxter biosciences - Neuchatel production technician, buffer and media prep 10/2006 - 09/2009 Formation production supervisor CREMO SA - Villars sur glâne, Fribourg Management of a team of 7 employees, in the industrial butter department. 2004 associate degree in food industry national dairy industry school Formation complémentaire  2018 first aid training  2017 MEWP permit  2014 quality documents change training  2014 Validation SIP / CIP training