Krzysztof Turek
Dublin
Summary
Hardworking person with nearly 20 years of experience in medical device, pharmaceutical and bio pharmaceutical industry. Highly creative and innovative with reputation for driving measurable results. I do enjoy of working in cross functional teams and start-ups. Currently focused to gain new skills in area of AI.
Overview
18
18
years of professional experience
Work History
SPECIALIST UPSTREAM MANUFACTURING
Bristol-Myers Squibb
Dublin
07.2023 - Current
- Working in Upstream area within Harvest/Cell Culture & Media
- Operating Bench Equipment: NovaCell, Vi-Cell, Microscope
- Operating STERIS Part washer and autoclave equipment
- KanBan Materials management
- Daily Sampling (NovaSept) and Sample submission
- CIP & SIP
- Aseptic Connections (DAC & MPC)
- Balance Daily Calibrations
- PH & DO probes calibration
- Peristaltic Pumps operation
- Production Batch Record reviews
BIOTECHNOLOGIST
Lonza AG
02.2022 - 06.2023
- Working in USP area (Start Up ORCA project)
- Writing SOP's and Work Instruction
- Overseeing construction works and equipment installation
- Safety Walks
- Defining strategies for Depth Filtration and Harvest Process
- Defining SWAB Process for USP area
- Defining strategies for FIT process for USP, Buffer/Media and DSP Area
- Including implementation of new to Lonza site FIT device (Sartocheck 5)
- CIP/SIP, FIT
- Media and Buffer Prep
- PPQ
MANUFACTURING TRAINING SPECIALIST
Viatris, formerly Mylan
Dublin
11.2018 - 01.2022
- Assisting in the development, implementation, and facilitation of technical/non-technical training programs and coursework covering all Manufacturing Operations (equipment and processes)
- Implementation and execution of Site Training Plans
- Identifying training needs
- Training new starters (setting up objectives and execution)
- Training Folder maintenance, audit readiness and archiving
- Training Matrix day-to-day updates and coordination
- Training Plans issuance and coordination
- External Visitors training (Work Permits)
- Cross-training employees
- Scheduling and delivering site training sessions.
- On-Boarding Curricula and Task-Specific Curricula (Issuance and updating)
- Leading Quality Investigations (SME), Complaints Laboratory experience.
- Validation Duties: Member of Validation Team - FAT/SAT participation - execution of validation protocols including: DQ, IQ, OQ and PQ (Upgrade 1st Device Assembly and Packing Line)
MANUFACTURING TECHNOLOGIST
Mylan
Dublin
10.2015 - 11.2018
- Operating Automatic Device Assembly and Packing Line
- Writing, updating reviewing SOP's, Work Instruction, Protocols, Reports, Production Batch Records
- Team Leader for Device Assembly Team
- Acting as Subject Matter Expert
- Area Training Coordinator - Maintaining and delivering training modules and related work instructions
- Designing Training Modules, Training Matrix
- Setting up personal training objectives, daily and weekly training reports for department
- Supporting internal, corporate, and external audit (HPRA, FDA)
- Quality inspections of components and finished product
- PMSI - carried on for incoming materials
- Problem solving using defined methodology (RCA)
- Kan-Ban implementation (dealing with several vendors, setting up a list of required items and location, minimum stock, delivery time)
- Risk Assessment Evaluation for equipment, process and area
- Supervisory duties
- MES and SAP
- Validation Duties: Member of Validation Team - FAT/SAT participation - execution of validation protocols including: IQ, OQ and PQ (for 2nd Device Assembly and Packing Line)
DEVELOPMENT TECHNOLOGIST
Mylan
Dublin
01.2012 - 10.2015
- Operating Semi - Automatic and Automatic Medical Device Assembly Lines and Testing equipment (DFAT - Device Final Assembly Tester)
- Writing, updating and reviewing SOP's, Work Instruction, Protocols, Reports, Production Batch Records
- Equipment Daily calibrations
- Sampling as per R&D protocols as part ANDA
- Defining Equipment and Area cleaning regimes
- Acting as Subject Matter Expert (SME) for product and equipment
- Supporting internal, corporate, and external audits (HPRA, FDA)
- Liaison with major stakeholders and vendors for plant visits
- Acting as coach for junior team members (Training Coordinator for department)
- Chemicals management: MSDS (Master Safety Data Sheet)
- Validation Duties: Technology transfer of Medical Device Production Line
- FAT/SAT execution of validation protocols including: IQ, OQ and PQ, Verification of Electrical and P&ID diagrams as part of FAT
- Purchasing equipment (balances, lifters), CAPEX
- PFMEA and FMEA of Medical Device and Packing Assembly Line
- Design of testing kit for Assembly Line
- Environmental monitoring of HVAC system: Operating Particle Counter, Settle Plates and Air Sampling
MANUFACTURING OPERATOR & MANUFACTURING TEAM LEADER
Gerard Laboratories
06.2008 - 09.2012
- Operating blistering/packing/bottling lines
- In Process Checks (IPCs)
- Daily calibrations
- Maintaining and review of Production Batch Records (PBRs)
- Quality Inspections and Investigations
- Finish Product Sampling
- Cleaning equipment and Maintenance
- Team Leading Duties
- Training duties
CLEANROOM PROCESS OPERATOR
Adecco, Hewlett- Packard Ltd
Leixlip
01.2007 - 01.2008
- Operating OAMs(Orffice Attaching Machines) in a high specification clean room (ISO regulated semiconductor manufacturing)
- Microscopic In Process Checks (IPC) of a product
- Maintenance and cleaning of production equipment
- Daily handover and troubleshooting reports
- Review Production Batch Manufacturing Records
GENERAL OPERATIVE
IBM International Holdings BV
Dublin
09.2006 - 12.2006
- Final Assembly and packing of computer servers
- Packing and unpacking finished units
- Final assembly and quality control checks
- Daily production handovers
Education
Postgraduate Diploma in Validation And Digitalization (LEVEL 9) - Validation, Digitalization and AI
Atlantic Technological University
Sligo, IrelandMASTER OF SCIENCE (LEVEL 9) - MEDICAL DEVICE BUSINESS & TECHNOLOGY
Innopharma & Griffith College
Dublin, Ireland01.2023
CERTIFICATE IN VALIDATION (LEVEL 7) - VALIDATION
Institute of Technology Tralee
Tralee, Ireland01.2020
CERTIFICATE IN BIOPHARMACEUTICAL PROCESSING (LEVEL 8) -
Institute of Technology Tralee
Tralee01.2020
CERTIFICATE IN CPD IN MEDICAL DEVICE DECONTAMINATION (LEVEL 7) -
Dublin Institute of Technology
Dublin01.2018
HIGHER DIPLOMA IN SCIENCE - PHARMACEUTICAL MANUFACTURING (LEVEL 8)
Institute of Technology Tallaght
Dublin01.2016
BACHELOR OF SCIENCE (LEVEL 7) - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
Dublin01.2014
HIGHER CERTIFICATION IN SCIENCE (LEVEL 6) - GMP - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
Dublin01.2012
CERTIFICATE IN ENGLISH AS FOREIGN LANGUAGE (LEVEL 8) -
Institute of Technology Tallaght
Dublin01.2010
BACHELOR OF ARTS - SERBIAN-CROATIAN LANGUAGE
University of Wroclaw
Wroclaw, Poland01.2006
Skills
- Lean Six Sigma Yellow Belt
- Syncade (MES)
- SAP
- Delta V
- PI - Vision
- LIMS
- MODA
- Documentum/D2
- TrackWise
- KNEAT
- Environmental Monitoring
- Quality Assessment
- Schematics Interpretation
- Root Cause Analysis
- Emergency Response
- Quality Assurance
- Resource Allocation
- Documentation Management
- System installations
- Validation & Commissioning
- Tech Transfer
Accomplishments
- I am proud to be a member of start up team within Mylan Dublin Respiratory Group (from R&D Scale to fully commercially operational plant, FAT, SAT, Tech Transfer)
- OJT's, SOP's, WI's and Protocols design, issuance, and execution
- Maintenance and Continuous Improvement of the Innovation and Learning Program (design new OJT - On the Job Training)
- Subject Matter Expert (SME) for current products and equipment
- Triage Team Member (Actively participating in QI/QIR, CAPA's)
- Validation Team Member (Design Review, Design Qualification, Transfer Technology)
- Member of cross-functional teams (Leading Quality Investigations)
- Supervisory duties
- Team Leader during Upgrade Project of Device Assembly and Packing line (4 months long project)
Languages
- English, C2
- Polish, Native
- Serbian, C2
- Croatian, C2
- German, A1
Timeline
SPECIALIST UPSTREAM MANUFACTURING
Bristol-Myers Squibb
07.2023 - Current
BIOTECHNOLOGIST
Lonza AG
02.2022 - 06.2023
MANUFACTURING TRAINING SPECIALIST
Viatris, formerly Mylan
11.2018 - 01.2022
MANUFACTURING TECHNOLOGIST
Mylan
10.2015 - 11.2018
DEVELOPMENT TECHNOLOGIST
Mylan
01.2012 - 10.2015
MANUFACTURING OPERATOR & MANUFACTURING TEAM LEADER
Gerard Laboratories
06.2008 - 09.2012
CLEANROOM PROCESS OPERATOR
Adecco, Hewlett- Packard Ltd
01.2007 - 01.2008
GENERAL OPERATIVE
IBM International Holdings BV
09.2006 - 12.2006
Postgraduate Diploma in Validation And Digitalization (LEVEL 9) - Validation, Digitalization and AI
Atlantic Technological University
MASTER OF SCIENCE (LEVEL 9) - MEDICAL DEVICE BUSINESS & TECHNOLOGY
Innopharma & Griffith College
CERTIFICATE IN VALIDATION (LEVEL 7) - VALIDATION
Institute of Technology Tralee
CERTIFICATE IN BIOPHARMACEUTICAL PROCESSING (LEVEL 8) -
Institute of Technology Tralee
CERTIFICATE IN CPD IN MEDICAL DEVICE DECONTAMINATION (LEVEL 7) -
Dublin Institute of Technology
HIGHER DIPLOMA IN SCIENCE - PHARMACEUTICAL MANUFACTURING (LEVEL 8)
Institute of Technology Tallaght
BACHELOR OF SCIENCE (LEVEL 7) - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
HIGHER CERTIFICATION IN SCIENCE (LEVEL 6) - GMP - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
CERTIFICATE IN ENGLISH AS FOREIGN LANGUAGE (LEVEL 8) -
Institute of Technology Tallaght
BACHELOR OF ARTS - SERBIAN-CROATIAN LANGUAGE
University of Wroclaw
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