Butterknowle, England, United Kingdom
With 20 years of experience in the pharmaceutical industry, I have developed extensive experience supporting within production and project environments across a diverse range of dosage forms, including MDI, MDPI filling, sub-assembly, vial and syringe inspection, packing, and bulk manufacture. Currently serving as an Engineering Team Manager in a cream/ointment bulk manufacturing facility, I lead a team of skilled engineering technicians to identify, troubleshoot, and resolve issues while delivering safe, compliant engineering solutions. My role focuses on planning and overseeing routine maintenance and statutory inspections to ensure equipment reliability, workplace safety, and equipment availability. I actively mentor my team, sharing my technical and process knowledge to improve their capabilities. In addition, I have extensive experience participating in and leading root cause analysis, Fmea's and fronting engineering topics during FDA and MHRA audits, as well as collaborating with the site's process safety team to ensure compliance with global engineering standards and PSSR regulations. As a time-served multi-skilled engineering technician, I have hands-on experience working with Atex-rated manufacturing equipment and previously held Compex EX01, EX02, EX03, and EX04 certifications. My strong technical foundation includes a solid understanding of PLC/DCS control systems, with specific training and experience in Siemens S7 and PCS7 DCS systems. I am proficient in providing production support, including calibration and maintenance of temperature, pressure, and conductivity systems. I have commissioning and validation experience in the sub-assembly and filling of MDIs, including the writing and completion of IQ/OQ packages. My technical expertise also extends to mechanical processing equipment such as high-pressure homogenizers, manufacturing vessel temperature control units, and handling hazardous process fluids and gases. Ensuring a strong safety culture is at the heart of everything i do. In my current role reasonable producing risk assessments and managing safe systems of work including confined space permits. 10 years as part of the site emergency response team including 1year as team lead responsible for 20 volunteers ensuring developing training plans and maintaining competence. Trained in incident command and control, comfortable taking charge of any major incident onsite from fire and first aid to loss of containment involving hazardous substances. Also trained breathing apparatus instructor.