Bern, Berne, Switzerland
Accomplished results driven Chartered Engineer with over 16 years industry experience working in highly regulated GMP environments. Extensive experience leading the execution of equipment commissioning & qualification for a wide variety of biotech process equipment including bioreactors, separators & filtration skids, media & buffer preparation & hold, CIP skids, as well as COTS equipment. In depth knowledge of cGMP practices, directly applied in developing and implementing risk-based approaches to Commissioning, Qualification and Validation in accordance with current industry best practice & regulatory guidance (ASTM E2500, ASME BPE, GAMP5, ICH & IPSE). Experienced in the generation, review and approval of departmental C&Q documentation e.g. (including SOPs, templates, master plans, commissioning protocols and final summary reports) and validation lifecycle documents (such as IQ, OQ, PQ, DQ and validation summary reports). Comfortable in leadership roles having led both service provider and client teams, to deliver on project milestones. Proven ability to quickly and effectively integrate within multi-discipline, multi-cultural teams. Strong communication and inter-personal skills with a high degree of initiative and self-motivation. Experienced with management of punches, deviations & change controls, including data analysis, root cause analysis and solution reporting. Maintains high standards in Health & Safety and has been a member of engineering & site safety teams. Experienced with the preparation of safety documentation including LOTO plans, PTW, SPAs, Risk Assessments & Method Statements & PSSRs.
Responsible for Media/Buffer Preparation and CIP areas.
CQV Lead, responsible for the commissioning and qualification of upstream processing equipment (Bioreactors, Centrifuge and Depth Filtration), Media/Buffer area and COTS (Commercial-Of-The-Shelf) systems at the Lengnau Biologics facility. Risk based commissioning and qualification of Siemens SIMATIC PCS 7 (DCS) based automated process equipment to GAMP5 standards. Managing external contract resources to deliver commissioning and qualification protocols. Generation, review and approval of system lifecycle documents (URS, QRA, RTM, DQ). Establish test templates, forms and procedures relating to commissioning and qualification aligned with current industry best practices (ISPE baseline guide vol 5) Review and approval of vendor design documentation (mechanical, electrical and software design specification). Review and approval of SMC documentation packs from construction team.
Senior CQV Engineer responsible for the commissioning and validation of large scale Production Bioreactors (4 x 18.5kL) and support vessels. Mechanical completion walkdowns and punchlist management working directly with vendors. Responsible for test protocol pre- and post-approval plus associated summary reports. Effective management of LOTO job plans. Safe system energization – Glycol, Clean Air, Black/Clean Steam managed through SPAs and Method Statement. Functional Control Module/Equipment Module field testing via Delta V Operate Operational phase and unit procedure testing via Delta V Explorer and Control studio, verifying configuration aligns with design documentation and functional system requirements. Risk based commissioning and validation of Delta V based automated process equipment to GAMP5 standards. Controller tuning via PID and Deadband control for temperature, pressure and flow control.