Switzerland
Automation Engineer | Lonza, Visp, Switzerland I am an Automation Engineer with hands-on experience in process automation and system validation within the pharmaceutical and biopharmaceutical industries. My expertise lies in designing, commissioning, and qualifying automated systems that meet the highest standards of quality, compliance, and reliability. Core Expertise: DeltaV Process Automation (USP/DSP/BMS/SIP/CIP, Configuration, Troubleshooting & Design) Commissioning & Qualification Computer System Validation (CSV) IQ/OQ/PQ protocol generation and execution Industry Knowledge: Strong understanding of GAMP 5 guidelines, GDP, and cGMP practices Skilled in implementing and optimizing automation solutions across upstream and downstream processing Experienced in control module, equipment module, phase, and recipe updates/modifications I bring a proven track record of problem-solving and system optimization that enhances operational efficiency, ensures compliance, and supports successful project delivery in highly regulated environments.
ORCA Project DeltaV From early recipe configuration to process qualification
Janssen BioCork2 & BioCork3.2 Project: DeltaV • Part of the C&Q automation test team for software developed during the BioCork2 project. Code reviews to EM Classes, Phase Classes, Unit Classes, Interlocks, and facility software instantiation – CMs, EM’s, Units across both upstream and downstream. Testing of Batch Software configuration (Recipes, SFC’s) and live graphics using P&ID’s. • Documenting full scope of test execution, including any flagged issues and implementing appropriate solutions to ensure Janssen are supplied with code that reflects the intended functionality. • Implement system code changes on multiple units across downstream whilst following cGMP and J&J guidelines. • Connecting with cross-functional teams to prepare the Process Automated System for Janssen's next product which requires effective communication through daily/weekly meetings, strict scheduling, and strong knowledge of project goals to assure targets are met and informing the wider team members of any automation difficulties. • Work with operations to provide the functionality as laid out in proposals, following through to commissioning and hand over of equipment back to production. • Participate in Quality Investigations (QI's) and follow-up actions from incidents onsite. • Provide onsite DeltaV shift support to operations for issues arising from day to day activities. • Worked closely with Engineering to develop, coordinate, and execute validation documents. Responsible for the pre- and post-execution review of the unit test scripts, analysis of tests and verification of submitted data and reports. • Serve as a subject matter expert on manufacturing system change procedures, qualifications, and validations non-compliance issues. • Provided training to the Execution Systems team on Janssen's J&J change control process, DeltaV upload/download principles, GDP guidelines, and regulatory requirements. •FAT/SFAT/DSAT
Private one to one tuition to Leaving and Junior certificate students in both Higher & Ordinary level Mathematics. Provided tuition to University students in Mathematic modules for various different courses. Modules include: Engineering Maths 101 and 102 Engineering Mathematics 211 Engineering Maths Methods Stats for Engineering 301 Maths for Engineers Maple
• Generation and execution of IQ, OQ, PQ reports for validation activities surrounding new Shot Peen machine. Carried out necessary testing, data collection, statistical analysis and reporting to Snr Management. • Perform hazard analysis on the new equipment and operational system to ensure safe working conditions. Provide expertise in risk management when facilitating completion of FMEAs within a cross-functional team. • Responsible for the design of the Shot Peen Trollies & Shot Peen floor plan, generating manufacturing documentation and processes (Bill of materials (BOM) management, tools, procedures (SOP’s), signage & drawings). • Drive LEAN manufacturing principles and Six Sigma methodologies throughout the sites work cells. Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labour efficiency, and throughput. • Installation of new equipment into cleanroom & witness FAT/SAT testing. • Conducted Gauge R&R on products in development using CMM & Minitab. • Review operators’ documentation to ensure compliance with Tecomet’s GDP/cGMP and external standards. • Ensure medical devices were within specification limits. Flag non-conformances & perform suitable Root Cause Analysis to determine root causes of internal/external issues. Put forward timely resolutions to limitations. • Audit support.
• Transport goods to areas of factory • Packaged goods to be delivered to customers • Use of large & small scale machinery to make product