Results-driven professional with a strong focus on process and attention to detail. Demonstrated ability to excel under pressure and meet tight deadlines. Acknowledged for outstanding collaboration skills and seamless adaptability to evolving requirements. Experience in equipment maintenance and process optimization, consistently upholding high standards of quality and safety
Overview
13
13
years of professional experience
1
1
Certification
Work History
R&D Process Technician 2
Catalent Pharma Solutions
06.2024 - Current
Technical:
Conducting experimental formulation & process studies as required
Conducting manufacture of cGMP batches for clinical and stability studies
Conducting qualification activities of new equipment
Conducting any other required experimentation as required
Providing resource support as required and ensuring critical milestones are achieved
Reviewing and approving completed batch documentation for all activities in a timely and accurate manner
Assisting in the review of proposed documentation, giving additional contribution to experimental design for assigned activities
Business and Financial Awareness
Being aware of resources required to conduct assigned tasks e.g. manpower, equipment, materials and ensuring they are available in a timely manner
Prioritizing assigned activities to meet timelines
Being aware of financial impact of project milestones
Making proposals and assisting in initiatives to improve efficiency or overall quality of development process
Being flexible in approach to working hours in order to achieve business goals
Regulatory and Compliance
Where required, carrying out all manufacturing activities to the appropriate standard, e.g. GMP, cGMP, SOP’s and protocols
Recording all data (live action data records, BMR’s, Data sheets, etc) in accordance with company procedures
Being aware of and complying with regulatory and company requirements for all documentation, with any deviation being discussed through the Quality department
Preparing, updating and approving process and procedure documentation as required
Ensuring all equipment is fit for purpose prior to use
Ensuring all areas of process, facility and equipment within control of this department are maintained to FDA / MHRA standards
Performing audits of work areas and documentation in use by the team on a regular basis, to ensure that all cGMP procedures are being followed
Health and Safety
Complying with Health & Safety requirements and assisting in COSHH / Risk Assessments as required
Ensuring that all procedures and tasks are carried out with regard to the safety of others
To report any dangers or hazards within the workplace.
Personnel & Development
Taking personal responsibility to ensure being adequately trained to execute assigned tasks
Working on special projects and project teams as required
Communication Skills
Liaising with other departments as required ensuring continuity of production
Ensuring assigned activities are completed within agreed timelines. and in compliance with current good manufacturing practices, observing company, customer and regulatory requirements
Ensuring safe working practices are employed, monitored and adhered to in accordance with the company health and safety policy
Conducting any other reasonable task as requested
R&D Process Technician 1
Catalent Pharma Solutions
Swindon
03.2021 - 07.2023
Technical:
Assisting with experimental formulation & process studies as required
Assisting with manufacture of cGMP batches for clinical and stability studies
Assisting with qualification activities of new equipment
Assisting with any other required experimentation as required
Providing resource support as required and ensuring critical milestones are achieved
Business and Financial Awareness
Prioritizing assigned activities to meet timelines
Being aware of financial impact of project milestones
Being flexible in approach to working hours, in order to achieve business goals
Regulatory and Compliance
Where required to carry out all manufacturing activities to the appropriate standard. E.g. GMP, cGMP, SOP’s and protocols
Recording all data (live action data records, BMR’s, Data sheets, etc) in accordance with company procedures
Being aware of and comply with regulatory and company requirements for all documentation, with any deviation being discussed through the Quality department
Health and Safety
Complying with Health & Safety requirements and interacting with COSHH/Risk Assessments
To ensure that all procedures and tasks are carried out with regard to the safety of others
To report any dangers or hazards within the workplace.
Personnel & Development
Taking personal responsibility to ensure being adequately trained to execute assigned tasks
Communication Skills
Liaising with other departments as required ensuring continuity of activities
Assisting in the development of suitably robust products & processing up to, and including ‘Demonstration batches’ to production
Ensuring assigned activities are completed within agreed timelines and in compliance with current good manufacturing practices, observing company, customer and regulatory requirements
Ensuring safe working practices are employed, monitored and adhered to, in accordance with the company health and safety policy
Conducting any other reasonable task as requested.
EH&S and Compliance
Catalent Pharma Solutions
Swindon
05.2020 - 04.2021
Writing Risk assessments
Drafting and developing health and safety procedures and policies
Carrying out site inspections and audits
Identify and correct potential hazards to environmental regulation compliance
Inspecting facilities, machinery, and safety equipment
Determining ways of reducing risks
Representing the company at internal and external safety meetings and audits
Reducing operational risks with proactive identification and mitigation of system vulnerabilities.
Delivering health and safety training courses for employees
Keeping records up to date and ensuring compliance with current health and safety legislation
EH&S Advisor
Catalent Pharma Solutions
Swindon
05.2019 - 05.2020
Recommending process improvements to enhance operational efficiency and safety
Developing long term strategies to reduce accidents
Carrying out risk assessments and site inspections
COVID-19 risk assessment for the entire company
Ensuring all equipment is installed in a correct and safe manner
Identifying potential hazards
Finding solutions to existing hazards and expanding health and safety knowledge
Running health and safety meetings and training courses for employees
Keeping abreast of new EHS developments through attending courses and maintaining contact with other EHS professionals and regulatory agencies.
Streamlining safety processes by developing and implementing standardized EHS procedures across the organization.
Process Technician
Catalent Pharma Solutions
Swindon
04.2014 - 05.2019
Filling in batch documentation and performing reconciliation of batches
Performing quality checks during manufacture
Performing inspections and tightened AQL inspections of batches
Ordering materials
Improving and developing work methods
Training new technicians in proper usage of equipment, safety protocols, and company procedures, ensuring a high level of competence across the team
Supporting an environment of safety through thorough knowledge of regulations, best practices, and consistent communication with team members regarding safe work habits
Reduced downtime for maintenance by performing regular equipment inspections and pre-operational checks
Process Technician
Johnson Matthey Fuel Cells
Swindon
10.2012 - 04.2014
CNC operator
Carrying out general production activities ensuring health and safety rules are adhered to
Training new technicians in proper usage of equipment
Maintaining detailed documentation of machining processes, enabling seamless shift handovers and knowledge transfer among team members
Maintaining strict quality control standards with thorough inspection of finished part
Reducing material waste through accurate programming of cutting paths and tool selection
Working closely with cross-functional teams to ensure seamless integration of CNC machined components into larger assemblies or systems
Troubleshooting and resolving complex CNC machining issues, minimizing downtime and maintaining production schedules
Process Technician
Catalent Pharma Solutions
Swindon
09.2011 - 09.2012
Filling in batch documentation and performing reconciliation of batches
Performing quality checks during manufacture
Performing inspections and tightened AQL inspections of batches
Ordering materials
Improving and developing work methods
Head Teacher and Owner of a Private English School
JLS Language School
Glogow, Poland
09.2011 - 09.2012
Maintaining accurate records of student attendance, performance, and progress to ensure transparency and effective communication with parents
Consulting with parents to build and maintain positive support networks and support continuing education strategies
Fostered a stimulating learning environment by maintaining well-organized and dynamic classroom spaces for daily use
Applying play-based strategies to provide diverse approaches to learning
Using advanced software to prepare documents, reports, and presentations
Oversight of daily operations, ensuring smooth functionality of business
Negotiating contracts with vendors for cost savings and quality assurance
Developing marketing plans to increase brand visibility and attract new customers
Education
Bachelor's Degree - English Studies
University of Zielona Gora
01.2002
Skills
H&S Industry Standards: OHSAS18001, ISO14001,45001
Methodologies of Lean, 5S, Kaizen
Knowledge of H&S rules
Ability to work under pressure
Problem solving
Strong communication skills
Quality control
Data analysis
Attention to detail;
Manage own work and others;
Good time keeping
Driving License
Technical troubleshooting
Procedure documentation
Certification
NEBOSH Health and Safety at work Qualification
NEBOSH General Certificate - pending
General Risk Assessment
COSHH Risk Assessments
DSE Assessor
Face fit testing
LANGUAGES
English: Native proficiency
Polish: Native proficiency
German: Professional working proficiency
Hobbies and Interests
Motoring, music, sport, traveling.
Timeline
R&D Process Technician 2
Catalent Pharma Solutions
06.2024 - Current
R&D Process Technician 1
Catalent Pharma Solutions
03.2021 - 07.2023
EH&S and Compliance
Catalent Pharma Solutions
05.2020 - 04.2021
EH&S Advisor
Catalent Pharma Solutions
05.2019 - 05.2020
Process Technician
Catalent Pharma Solutions
04.2014 - 05.2019
Process Technician
Johnson Matthey Fuel Cells
10.2012 - 04.2014
Process Technician
Catalent Pharma Solutions
09.2011 - 09.2012
Head Teacher and Owner of a Private English School