County Dublin, Ireland
A qualified Chemical Engineer with ample experience in CQV engineering within GMP environments. As a CQV Process Engineer, I focus on safety, compliance, and quality, generating and executing cGMP validation documentation Right-First Time. Optimizing manufacturing processes, ensuring quality, efficiency, and compliance while driving process improvements. Let's connect to discuss potential collaborations in the pharmaceutical and biotech sectors.
Process Equipment Engineer (CQV Engineer) and New Product Introduction Engineer - Provide engineering and technology support to Bulk Drug Substance (DS), Portable Laboratories Equipment (PLE) and Utilities. - Led CQV and validation activities across multiple projects, including DS1 Expansion, New Product - Introduction (NPI), ADC, and sustaining initiatives, ensuring GMP and regulatory compliance. - Managed facility and utility qualifications (CIP, Clean Steam, Process Drains) and executed final revalidation of the Steam Out of Place (SOP) panel, including temperature mapping, biological indicator testing, and final filter integrity checks. - Executed and monitored MCS/DeltaV batch recipes, performed ITS and CQV activities for new and modified processes, supporting NPI demo batches and process optimization. - Oversaw procurement, FAT/SAT execution, and integration of new lab and process equipment. - Led CAPA-driven safety improvements, managed GMP change controls, and delivered full validation documentation (URS, RV, IOQ, CQV, PQ, Summary Reports, ORR) on paper and electronic system (EDES/KNEAT). -Collaborated closely with cross-functional teams, construction managers, external vendors, and stakeholders to ensure smooth project execution and timely delivery. - Managed punchlists, deviations, and participated in the back room of audits ensuring regulatory adherence (FDA, HPRA, ANVISA, etc ). - Participated in Quality Systems activities: Document Management, Change Control, Non-Conformities, and CAPAs.
Process Engineer: Implementing and optimizing manufacturing processes. Ensuring product quality, efficiency, and compliance. Collaborating on process improvements and problem-solving.
- Proficient in the use of laboratory of instrumentation such as High Performance Liquid Chromatography (HPLC), UV-VIS spectrophotometer, Total organic carbon analyser (TOC), Karl Fisher, pH meters, Infrared Spectroscopy, moisturizer balance, auto pipette. - Support Laboratory inspection and audits - Implement and adhere to appropriate levels of cGMP within the laboratory. - Support any validation and qualification of test methods and processes. - Facilitate laboratory investigations and support associated product analysis. - Reporting of any stability OOT/OOS results. Participation in associated investigations and assessments. - Troubleshoot laboratory methods and instrument problems. - Author SOPs, protocols and reports in line with GDP as required - POC for the procurement of laboratory standards. Experienced in contacting vendors, requesting quotes, laising with Finance, PO approval and organisation/documentation of deliveries.
- Responsible for research, development and verification of analytical methods across a range of techniques as required to support projects. - Research and development of an oxidative process method along with analysing samples from various phases of the testing. - Laboratory analysis, chemical and physical testings, ensuring strict adherence to site policies, cGLP/cGMP and environmental, health and safety regulations. - Chemistry techniques such as HPLC, IR, UV & dissolution systems. In addition to titrimetric analysis, pH analysis and sample validation. - Operation, maintenance and calibration of laboratory instruments. Preparation and execution of instrument and method validation protocols. - Experience writing technical documents, including SOPs, batch records for operations and processes and scientific reports as well as analytical data reviews. - Analytical techniques and instrumentation of drug products and chemicals
- Engineering and environmental research into potential solid waste processes. - Develop construction products from recycled materials. - Laboratory testing and conversion of fat, oil and lipids to soap using the saponification chemical process. - Small scale production process was built in the university, including the implementation and maintenance of laboratory specific SOPs and test procedures. - Provide analytical support in troubleshooting and training for analysis methods and tools.