Product, process, validation engineer, process development, equipment

Shahlo Lawrence CV

Tel: +353-********* E-mail: **************@*****.***

EDUCATION

Jan 2013 – Oct 2013: Lean Six Sigma Greenbelt, Waterford Public Training Course. (Yield Defect Reduction resulting $10.000 savings per month at Honeywell Turbo Technologies) Jan-May 2013: Lean Manufacturing Tools Program, Carlow Gateway Business Centre. Jan-May 2013: CAD 2D, FAS Level 2, Waterford FAS Training Services 2005-2006:CNC Programming, FAS Level 2, Waterford FAS Training Service Waterford (Ireland) Institute of Technology:

Graduated 2013: MSc in Innovative Technology Engineering. Graduated 2012: Bachelor of Science (Honours) in Manufacturing Engineering. WORK EXPERIENCE

Career Break July 2026- October 2026- Travel Across Asia Boston Scientific, Clonmel, Ireland May 2022 -July 2026 Position: Senior Process Development Engineer (P&D) Full-time employment in a fast-paced medical device company specialised in manufacturing Pacemakers (defibrillators) class III active implantable devices driven by ISO 13485.

● Defining project scope, objectives and deliverables.

● Create and manage project timelines.

● Coordinate engineering, validation, quality and manufacturing teams.

● Lead project meetings and trace task completions.

● Maintains detailed documentation throughout all phases of development.

● Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.

● Coordinates execution and documentation of validation builds Process Validation and Qualification.

● Coordinates testing of validation units, and the compilation, analysis (using Minitab Quality tool), and reporting of the validation results.

● New equipment introduction URS, FAT, SAT, OQ/PQ, PQ/PV (including Process change, Equipment Procedures, Risk assessment/ FMEA Process characterisation, Tool Qualification, Work instruction, Validation Master Plan)

● Understands and complies with all the regulations guidance of current US FDA and EU validation requirements.

Viatris Damastown - Global Pharmaceutical Company Dec 2021-May 2022 Position: Senior Validation Specialist

Full-time employment as a validation engineer in the pharma healthcare industry. Viatris is a global pharmaceutical company committed to providing access to high-quality medicine for the world's 7 billion people. Every day, patients in more than 165 countries and territories depend on our approximately 35,000-strong global workforce to deliver on that promise. Fully regulated by Shahlo Lawrence CV

ISO 18001 demonstrated a strong commitment to safety excellence and strong levels of trust. Key elements included:

● Responsible for leading and executing Qualification and validation strategies for key site processes (manufacturing/packaging) and ongoing process validation, in line with current regulatory requirements, corporate policies, and site procedures (as per Validation Master Plans), including the generation/review of validation documentation (schedules/Risk Assessments/Protocols /Reports/Annual Reports/).

● Update MVP’s/risk assessment (live document) to reflect related changes

● Presenting executed qualifications during internal and external audits.

● Ensuring that a continuous state of validation is maintained for site equipment, systems, and utilities, including providing validation input for site Change Controls

● Perform validation functional testing as required. Track and resolve deviations during qualification activities.

● Perform gap analysis on the site procedures for areas of responsibility against current regulations and corporate policies and adapt site policies/SOPs to comply with the latest regulatory and corporate expectations.

● Perform review activities of Validation Specialist documentation (and approval in the absence of the Senior Technical Services Manager).

● Mentoring of Validation Specialists within the department as required.

● Participate in the site change control system affecting pharmaceutical products and medical devices, ensuring that all changes to validated processes and systems are introduced in a formalised manner.

EirGen Pharma, Ireland Dec 2018- Dec 2021

Position: Validation Engineer Team Lead

Full-time employment as a validation engineer in the pharma healthcare industry. EirGen Pharma is a world-leading developer and commercial supplier of specialty medicines to the global market. Fully regulated by ISO 18001 demonstrated a strong commitment to safety excellence and strong levels of trust.

Key elements included:

● Manufacturing Line set-up including IQ’s, OQ’s and related Validation Documentation for sachet packaging equipment.

● Write and execute validation protocols and reports for oral dose products of new and existing processes including post-validation continuous process verification. The manufacturing process involved dispensing, blending, compression, and coating for tablet products and dispensing, blending, encapsulation, and weight sorting units of capsule products as per effective BMRs.

● Write and execute packaging validation protocols and final reports on Blister and Bottle packaging for oral dose products to demonstrate that the commercial Packaging Process performs as expected.

● Analyse statistical data to verify acceptable criteria.

● Provide technical support/troubleshooting for process and equipment issues.

● Investigate/resolve discrepancies and deviations associated with validation studies.

● Draft/ revise/ review SOPs.

Shahlo Lawrence CV

● Ensures processes and procedures are in compliance with US FDA, EU and ROW (rest of the world) regulations.

Bausch &Lomb Waterford, Ireland Feb 2015- Dec 2018 Position: R&D Process Development Engineer

Full-time employment in research and development for the contact lens industry. Specialising in R&D production interventions for the purposes of supporting lens development and clinical trials. A fast-paced fully regulated ISO 13485 environment manufacturing class II medical devices for a global market. Products manufactured and developed as daily disposable use both single vision and Toric optics. Performing as a Validation leader for new product development. Key elements included:

● Reviewing, authoring, and execution of manufacturing protocols and reports. Planned interventions on live production manufacturing lines.

● Authoring, and execution of development protocols. Smaller-scale exploratory and feasibility work on dedicated R&D line to support design innovation.

● Statistical data analysis utilizing Minitab and Tableau software.

● Supporting existing manufacturing in-processes optimization, yield, and quality improvements.

● Process troubleshooting and reducing variability within the manufacturing process.

● Rollout of new WI/SOPs to manufacturing personnel.

● Working as a key member of multiple new product development and process validation.

● Mentoring & training of manufacturing and junior personnel in required operations. Boston Scientific, Clonmel, Ireland Aug 2014-Feb 2015 Position: Manufacturing Engineer

Full-time employment in a fast-paced medical device company specialised in manufacturing Pacemakers (defibrillators) class III active implantable devices, supporting over 250.000 lives to date.

● Running Yield report on a daily and weekly basis.

● Implementing Lean Manufacturing around Hybrid area through Kaizen activities.

● Conducting an audit on 6s while creating a “To-do list” to keep up with the standards.

● Material Cost Reduction project, conducting studies and research to bring spending under control.

● Performing components inspections.

Bausch & Lomb Waterford (Internship)Mar 2014- Aug 2014 Position: Process Development Engineer.

● Execution of R&D protocols in a specialised development laboratory.

● Analysis and report generation.

● Analysing and summarising the results.

● Performing study on measurement gauges to reduce the variations in the process. Shahlo Lawrence CV

Honeywell Aerospace Ireland, Waterford (Internship)Oct 2013- Mar 2014 Position: Lean Manufacturing Support Engineer

Full-time employment in production support for an aerospace industry leader. A fast-paced work environment, manufacturing blades for US military helicopters, and fixed wings aerocrafts. Project to reduce parts manufacturing time utilising Kanban schedule system.

● Implementing 5S elements and visual management around machine cells in order to improve manufacturing operations (pull instead of push system)

● Developing and applying new standards for continuous process improvement.

● Implementation of Kanban system in conjunction with cycle time reduction. (Managed to reduce manufacturing time from 9 to 7 days)

● Conducting an audit on introducing 5S on weekly basis for successful sustainability. Honeywell Turbo Technologies (Internship)May 2013- Oct 2013 Position: Manufacturing Engineering Assistance

Full-time employment in production support for the transportation industry leader. A fast-paced environment plant, manufacturing turbo blades for all types of diesel cars. The main project was based on reducing the damage/scrap percentage by utilising six sigma techniques.

● Conducting trials to eliminate variations in the manufacturing process (reduced scrap rate by 13%)

● Presenting a 'scrap review' through a graph based on weekly collected data. Genzyme Pharmaceutical, Waterford (Course Project)Jan 2012- Oct 2012 As part of the Master’s Programme, I participated in a project in Genzyme Pharmaceutical. This entailed working in the plant for 9 months and completing a project on the “Feasibility of Implementing a Vision System in the Pharmaceutical Industry”. AOL Broadband Phone Company, Co. Waterford (part-time)2007- 2009 Position: Customers Services, Billing, and Sales Assistance.

● Solved billing issues over the phone, checking against the computer system and updating the customers’ accounts. Liaised with customers by phone to resolve billing issues and ensured speedy resolution.

● Ensured customer queries were dealt with efficiently resulting in strong customer satisfaction.

Majestic Hotel, Tramore, Co. Waterford (part time)2006- 2007 Position: Restaurant Supervisor

Self-Employed, Main Street Tramore, Co Waterford 2002-2006 Position: Dressmaker, Seamstress.

Shahlo Lawrence CV

City Service, Uzbekistan 1996-2002

Position: Electrical Maintenance Supervisor

● Trained staff (11 team members) on electrical maintenance safety and best practices ensuring high standards of operation and compliance with Health and Safety Regulations of Uzbekistan.

● Managed preventative maintenance projects, liaising with government departments to ensure the power was switched off to allow the work to take place. ADDITIONAL INFORMATION

● Strong analytical, and problem-solving with good written and oral communication skills

● Results driven. Highly responsible and capable of working under pressure to meet deadlines.

● Ability to prioritize multiple tasks and execute projects on time in a fast-paced environment.

● Ability to communicate clearly the timelines and important milestones

● Good team player and collaborative working style.

● Detail-oriented professional

REFERENCES AVAILABLE UPON REQUEST

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