Krzysztof Turek
Training Expert
Warsaw,Poland
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
4
4
Language
Work History
SPECIALIST UPSTREAM
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
MANUFACTURING TRAINING SPECIALIST
PPQ, Viatris, 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 - 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
- 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 audits (HPRA, FDA)
- Quality inspections of components and finished products
- 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 - 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 - Validation And Digitalization
Atlantic Technological University
MASTER OF SCIENCE - BUSINESS & TECHNOLOGY
Innopharma & Griffith College
01.2023
CERTIFICATE IN BIOPHARMACEUTICAL PROCESSING - undefined
Institute of Technology Tralee
01.2020
CERTIFICATE IN CPD IN MEDICAL DEVICE DECONTAMINATION - undefined
Institute of Technology Tralee
01.2018
HIGHER DIPLOMA - SCIENCE : PHARMACEUTICAL MANUFACTURING
Dublin Institute of Technology
01.2016
BACHELOR OF SCIENCE - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
01.2014
HIGHER CERTIFICATION - SCIENCE
Institute of Technology Tallaght, GMP PHARMACEUTICAL TECHNOLOGY
01.2012
CERTIFICATE IN ENGLISH - undefined
Institute of Technology Tallaght
AS - FOREIGN LANGUAGE
University of Wroclaw
01.2010
BACHELOR OF ARTS - SERBIANCROATIAN LANGUAGE
Institute of Technology Tallaght
01.2006
Skills
Management collaboration
System installations
Team performance improvement
Multitasking
Problem-solving abilities
Team building
Multitasking Abilities
Technical communication
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)
Affiliations
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)
Work Preference
Work Type
Full TimeContract WorkWork Location
On-SiteRemoteHybridImportant To Me
Work-life balanceFlexible work hoursPersonal development programsStock Options / Equity / Profit SharingHealthcare benefitsCareer advancementLanguages
Polish
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
Serbian
Bilingual or Proficient (C2)
Croatian
Bilingual or Proficient (C2)
German
Elementary (A2)
Certification
Lean Six Sigma - Yellow Belt
Train The Trainer
Timeline
SPECIALIST UPSTREAM
Bristol-Myers Squibb
07.2023 - Current
BIOTECHNOLOGIST, Lonza AG
02.2022 - 06.2023
MANUFACTURING TRAINING SPECIALIST
PPQ, Viatris, 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 - Validation And Digitalization
Atlantic Technological University
MASTER OF SCIENCE - BUSINESS & TECHNOLOGY
Innopharma & Griffith College
CERTIFICATE IN BIOPHARMACEUTICAL PROCESSING - undefined
Institute of Technology Tralee
CERTIFICATE IN CPD IN MEDICAL DEVICE DECONTAMINATION - undefined
Institute of Technology Tralee
HIGHER DIPLOMA - SCIENCE : PHARMACEUTICAL MANUFACTURING
Dublin Institute of Technology
BACHELOR OF SCIENCE - PHARMACEUTICAL TECHNOLOGY
Institute of Technology Tallaght
HIGHER CERTIFICATION - SCIENCE
Institute of Technology Tallaght, GMP PHARMACEUTICAL TECHNOLOGY
CERTIFICATE IN ENGLISH - undefined
Institute of Technology Tallaght
AS - FOREIGN LANGUAGE
University of Wroclaw
BACHELOR OF ARTS - SERBIANCROATIAN LANGUAGE
Institute of Technology Tallaght
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