Michal Banas

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Process Operator

Kinsale, Co. Cork

Michal Banas

Address: 14 The Court, Compass Quay, Kinsale, Co. Cork

Mobile:  087 ‒ 133 – 28 – 69

E-mail:  [email protected]

Personal Profile

Process Operator experienced in the Pharmaceutical/Biopharmaceutical Industry, working within a team environment. Confident and energetic, possessing strong communication and interpersonal skills. Highly flexible with a genuine interest and commitment to continuous improvement, operating to current Good Manufacturing Procedures (cGMP), FDA and IMB standards.

 

last Employment 

GE Healthcare Ireland Ltd. – Carrigtwohill, Co. Cork                                                              2017 – now

UP-STREAM – TANK ROOM – PROCESS OPERATOR

• OpEration of the process and equipment in Grade C Cleanroom environment, in accordance with the Batch Record, design parameters and current Standard Operating Procedures

• GE Healthcare Cleanroom Driving License

• Adhering to GE Healthcare Global Policies, Procedures and Guidelines, regulatory requirements and executing

Current Good Manufacturing Practices (cGMP) and application of Good Documentation Practices (GDP) in the performance of day to day activities

• Responsible for preparing pharmaceutical solutions that are ultimately filled within aseptic sterile filling areas into small volume units

• Keeping accurate records as needed for solution manufacture and prepares solutions as directed by work order

• Operation of the SIMATIC 7 Siemens Distributed Control System (DCS) and Millipore UF RIG DCS, imputing PTS, QS, CIP, SIP recipes

• Using MODA (Mobile data Acquisition) computerized system for creating barcode labels for Glove Prints Samples

• On-the-floor operation of process equipment including Mixing Tanks, Hold Tanks, UF Rigs, pipework, pumps

• Performing set-up, cleaning, and operation of complex equipment, chemical testing, mixing drugs, filtering and drug weighing

•  Draining Jackets, attaching Vent Hoses, PTS Spray Balls, PTS Bungs, tare the Mix Tanks and Hold Tanks weight before and after proceeding, inserting Profiler Pre Filters 0.2um (filter cartridge), connecting Spool Pieces,

connecting pipework and hoses, assembling Filter housing

•  Setting up UF Rig for processing, Imputing batch information on to Millipore Control System

•  Receiving and verification of all raw materials, adding of API and Excipients into batch in accordance with GMP requirements

•  Performing CIP – Clean In place used for cleaning process equipment and process lines using WFI at a temperature  of over 75ºC and SIP – Steam In Place used to sterilize process equipment and lines with pure steam at a temperature of over 124ºC of Mix Tanks, Hold Tanks, UF Rigs, Process Transfer Lines, etc.

•  Soft parts change out i.e. gaskets on pipework, filter changing etc. Basic engineering of the equipment used in bulk manufacturing e.g. pipe-work, valves, pumps, Mixing Tanks, Hold Tanks, etc.

•  Using Profiler Pre Filters; 0.2 um Filter used in batch production which is placed in a housing for the product to be filtered before going through Ultra Filtration Rig and in Non-UF process

•  In Process Sampling and sample testing after Excipients addition, L1 (to measure the level of endotoxins present), B1 (to measure the level of viable microorganisms  before sterilization), Final samples which are taken to establish the efficacy of the product

•  Using RI meter to measure the specific gravity, which is used to identify the concentration of the product

•  Using PH meter for measure Acidity or alkalinity of product

•  Routine calibration of analytical equipment

•  Performing calculations and conversions involving weights, volumes, and percentages

•  Monitoring and collecting data during process operations, printing CIP Reports, updating Status Boards

•  Recognizing when processes, procedures, equipment, product, excipients, etc. are out of specifications

•  Communicating relevant information regarding production to incoming shift Supervisors, Leaders, dispensary operators, filling lines operators, QC personnel

•  Work on Day/Night Shift Rotation, weekend’s shifts and some non-scheduled call-in time to respond to plant emergencies etc.

• Set-up and operating various Bausch+Ströbel computer controlled production equipment, i.e.: Vial/Bottles washer,

Capping machine, Tray-up machine, etc

• Following instructions (SOP’s, Batch records) for completion of job tasks

• Accurate completion of documentation (batch records, production reports, LUMAC log books) in compliance with

cGMP standards

• Cleaning and sanitization of all equipment/rooms used in the manufacture of products according to SOPs

• Responsible for working as part of an empowered team to achieve daily/weekly production targets

• Housekeeping and materials management in all production areas while focusing on continuous process

improvement using Lean Principles

• Ensuring that 5s standards are maintained

• Confident working with multiple products to meet business needs as per the production schedule requirement

• Ensuring that safety risks are identified and reported on in a timely manner

• Proper labelling and inventory management

• Report and record all deviations

• Deactivation of waste i.e. Product waste in safe and GMP manner

• Strong analytical and problem-solving skills

• Operation of Forklifts, Pallet trucks

 

ABBVIE – Fournier Laboratories Ireland Ltd. – Carrigtwohill, Co. Cork                       2015 – 2017

PROCESS OPERATOR

GEA NIRO FLUID BED DRYER Operator

•  Operating of the GEA Fluid Bed Dryer and Solution Tank SPB

•  Setting up, operating, disassemble the equipment, cleaning, troubleshooting and changing over the GEA Fluid Bed

Dryer and Solution Tank SPB as per SOP and as per specifications in Production Batch Record

•  Using GEA SCADA1 Integrated Software control systems, SAP program, CHALLENGER18 Remote PC-Terminal

•  Operation Granulation equipment independently, as well as working in a team environment

•  Loading and discharging products from Fluid Bed Dryer

•  Developing and understanding of spray dryer operation, characteristics, limitations, and hazards

•  Taking in process parameters during the product run, and document these measurements in Production Batch Record.

•  Monitoring granulation operation periodically and report any abnormal conditions to the Supervisor

•  Carrying out (after the drying cycle) LOD testing using Mettler Toledo Hr 73 Moisture Analyzer to ensure the product was dried is within accepted specifications

•  Commissioning and validating activities for new pieces of equipment and processes to the appropriate

standards and guidelines, where relevant

•  Operation of FBD PTS Filter Oven, Filter Washing Machine JLA HW131, Filter Miele Dryer, Scales in

Manufacturing Area, Forklifts, Pallet trucks

•  Clear communication with Mill operators, QA technicians and Maintenance to ensure product is received and delivered to and from the dryer in the proper manner to assure a quality product is produced

•  Making sure all paperwork is complete and accurate throughout and after production

•  Following company safety rules and use appropriate PPE and safety gear provided

•  Executing all operations activities in a safe manner and in strict accordance with SOPs, cGMP regulations and site  Quality standards

•  Operate CIP process equipment in accordance with quality system procedures

•  Performing daily and weekly housekeeping duties to maintain a clean and sanitary environment in the NIRO areas

•  Visually inspect equipment as it is running to verify the machine is running within the normal and safe operation

•  3 Cycle and 4 Cycle 12 hours Shift work

SIFTER  Operator

•  Operating GERICKE Sifter

•  Sifting Granulate and Excipients

•  Using SAP system for entering data of Processed Batch

•  Operation of Scales in Manufacturing Area, Forklifts, Pallet trucks

•  Disposing waste of Oversize Granulate

•  Using 1200ltr and 2000ltr IBC’s

•  Performing CMA or CMI of Sifter and Sifting room

SORTING/PACKING Operator

•  Using SAP program, Transactions: CO60 (opening correct P.I sheet for batch), COWBHUWE and VL74, etc.

•  Completing Batch Records, Logbooks, Sampling Plans, Line Clearance forms, etc.

•  Checking IBC with Tablets against Batch Number to ensure correct IBC is in use, placing IBC on loading platform,

•  Set-up, start-up and Operating MASCHIMPEX DIASORT 8 Packaging Line:

§   preparing drums

§   Filling drums with required amount of tablets – weighting on SARTORIUS-COMBICS 3 weight scale

§   Performing Metal Checks,

§   Sealing Complex bags on BERNHARDT – heat Sealer press

§   Labelling drums, fitting seals

§   Loading of packaging components/materials at the line (drums, Complex bags, PE bags, labels, printer consumables, seals, pallets, etc.)

•  Sampling – checking Batch Number on Micro, Retain and Chemistry Sample Labels, Preparing Customer Sample

and AQL Labels, Preparing Samples containers, Completing Sampling Plan Form, Recording results in P.I Sheet and

Batch Record, Inspecting Tablets Samples at each stage of Sorting and Packaging, Submit Samples for QC collection

•  Completing Reconciliation in SAP PI sheet and batch Record

•  Conducting Line Clearances, sorting/packaging room post batch Minor cleaning CMI, Major cleaning CMA and changeovers

Other Duties

•  100% Inspection of tablets

•  Weekly Scales verification

•  Operation of Washing Booth and washing various sizes IBC’s, Small Parts, Machines and Equipment

•  Preparing Cleaning/Sanitizing Solutions (with Klericide X, Budanet or Klericide B)

•  Operating Jungheinrich Ride-on and Walked operated fork lifts

•  Manual Handling Training, Site Induction Training, GMP Induction Training, 3M Qualitative Fix-test Record

•  CMI or CMa of Cleanroom’s, Dispensary Rooms, Containment Safety LAF Booths prior Batch preparation

WAREHOUSE Operator                                                                                                                              2015

• Prepare and packing batches of products for dispatch on a daily basis in a timely fashion in line with customer

requirements

• Competently managing the Preparation of materials for sampling which includes cross function interaction with the

QC department on a daily basis, without added supervision

• Ensure all stock is put away in locations/racks in a safe and secure manner

• Ensure warehouse areas, yard areas and front area of the premises are maintained to a high level of housekeeping

standards and are kept in an orderly and safe fashion at all times

• Adhere to company Health and Safety policies and procedures at all times

• Operating Jungheinrich Powered Pallet trucks, Stainless Steel Powered pallet trucks

• Loading and unloading of trucks, checking delivery documentation

Upskilling
 

WORK PLACEMENT                                                                                                                                2015

ABBVIE – Fournier Laboratories Ireland Ltd. – Carrigtwohill, Co. Cork

• Operating MASCHIMPEX Packaging Line – preparing drums, filling drums, weighting on SARTORIUS-

COMBICS 3 weight scale, sealing bags on BERNHARDT – heat Sealer press, labelling, fitting seals,

stacking on pallets, putting pallets with drums in to Kanbans

• Cleanroom Sanitization, CMA of Dispensary Rooms prior Bath Preparation, Cleaning Containment Safety LAF Booths

• Preparing Cleaning/Sanitizing Solutions (Klericide X, Budanet, Klericide B)

• Shadowing manufacturing personnel operating Rotary Tablet Press Machine to gain experience of same

• Assisting at Batch Preparation, Dispensing/Sorting/Packing materials

• Adhering to a Health and Safety, GMP and PPE requirements on site

Merck Sharpe Dohme (MSD) – Brinny, Innishanon, Co. Cork                                                  2015

• Working in Continuous Improvement Department within Sterile manufacturing area

• Shadowing Manufacturing Personnel during Parts Preparation, Compounding, at Vial Wash line, Filling

Line, Packaging and Inspection, batch preparation in API department (Culture Prep Lab, Seed tank,

Fermenter, Sterilizer, Centrifugation, Antifoaming, Program ABB), in Utility room, etc.

• Using communication systems which are used in MSD Brinny as: Microsoft Outlook

system, CITRIX, My Learning, SYNC Brinny, MyCareer, MIDAS – Merck Integrated Document

Architecture Services, [email protected]

• Participating in: daily operational Tier meetings with tier display boards in the corridors outside of the

OPS1 and OPS2 manufacturing areas within the Sterile IPT Manufacturing area

• Participating in trainings: Site Induction (EHS, Quality, GMP, HR, H&S, IT), Manual Handling, etc.

• Searching, filing, printing of Merck’s Environmental, Health and Safety (EHS) Standards, SOP’s, Batch Records and other documentation

Upskilling
LIFE SCIENCE MANUFACTURING OPERATIONS – BIOPROCESSING                         2014 – 2015

CETB Cork Training Centre Biopharma Facility – Carrigaline, Co. Cork

Award:   Life Sciences Manufacturing Operations QQI Level 5 Major Award

Modules (include knowledge and practical skills):

Health Safety and Environmental Awareness including Health and Safety Regulations, conducting Risk Assessments, completion of Incident Reports, hazardous Spill Clean Up. Dispensing solids and liquids using various balances and pipettes, using Glovebox Isolator

Quality and Good Manufacturing Practice including Regulatory Requirements, Quality Systems including Change Management and Document Control, generation of Standard Operating Procedures (SOPs), completion and GDP review of Manufacturing Batch Records, preparation of Non-conformance Reports

Continuous Improvement in Manufacturing: Lean Tools and Six Sigma

Cleanroom Operations: including Microbiology, Cleanroom design and operation, Contamination Control. Operation of Autoclave. Using Aseptic Technique for garbing for ISO class 7 Cleanroom, room Sanitization, Transfer of Materials and Equipment, Environmental Monitoring (including use of Contact Plates, Settle Plates, Particle Counter and microbial Air Sampler)

Plant Utilities including water, steam and HVAC systems, Process Gases, Fluid Transfer and interpretation of P&IDs. Operation of Purified Water Skid, High Shear Mixer and Delta V

Bioprocessing including Contamination Control, Upstream and Downstream Processing. Operation of Disposable Stirred Tank and Automated Bench-top Bioreactors, Integrity Testers and Ultrafiltration Unit

Team Working including building effective teams

Employment History
Perryville House Hotel  –  Kinsale                               2012 – 2014          Hotel Porter

•   Checking in and checking out guests using the hotel’s accounting system

•   Point of contact for guests should they have any queries

CLEARSPHERE LTD.  –  Carrigaline, Co Cork                                                                        2006 – 2012

Cleanroom & Containment Systems Fitter

v       Cleanroom and Containment Engineering  –  e.g. in: Stryker Cork, Novartis Ringaskidy, Pfizer Loughbeg, Alcon Cork, Centocour Ringaskidy, Servier Arklow,  Schwartz Pharma Shannon, Takeda Bray, Schering Plough Briny, Genzyme Waterford, Astellas Kilorglin, Lake Region New Ross, etc.

•  Installation and maintenance of Cleanroom, Cleanroom ceilings (walk-on and non-walk-on), doors and

windows, coving, wall protection, lighting, Cleanroom equipment and furniture

•  Installation and mechanical maintenance of Downflow Containment Booths, Glove Box Isolators, Charging

Booths, Solvent Booths, Powder Handling Booths, LAF hoods, Sampling Suites, Filter Housings, etc.

•  Installing Cleanroom partitioning, fire rated systems, modular ceiling components, industrial partitioning,

Cleanroom accessories, hygienic PVC wall cladding etc.

•  Working in Live Highly Regulated Pharmaceutical manufacturing environment as part of a team or

independently

•  Operating Forklifts, MEWP, pallet stackers and other relevant equipment

v       Assisting at Validation – e.g. in: DePuy, Stryker, Glaxo Smith Kline Cork, Hovione Loughbeg, Wayeth Askeaton, Takeda Bray, Genzyme Waterford, GSK Dungarvan, Janssen Little Island, etc.

•  Cleanroom testing and qualification, Powder Booth testing, Solvent Booth testing, Safety Cabinets                     testing, Fume Cupboards testing, Isolators, Laminar Air Flow Hoods (LAF), and Air Handling Units                   (AHU)

•  Carrying out the Typical tests as: Installed Filter Leakage Test, Room Pressure Differential Tests,

Airflow/Air Volume Tests, Airborne Particle Count Test, Airflow Visualization Test, Airflow Direction               Test, Room integrity/leak test

•  Carrying out the measure of Temperature, Humidity, Sound and Light Level.

•  Using: FOG Generator, Air Capture Hood, High Pressure Diffuser, Electronic Micromanometer,                        Particle Counter, Photometer, Digital Thermometer-Hygrometer, Digital Anemometer and Sound                       Meter

•  HEPA/ULPA filters testing and re-placing

v      Maintenance

•  Emergency Maintenance and Re-validation

•  Repairing or replacing Filters, Gloves, O-Rings, Seals, Belts, Drives, Automatic Doors, Hinges, Sensors,

Ductwork, Roller Conveyors, Magnehelic Gauges, Flexible-PVC-Curtains, etc.

Academic Qualifications
AGH University of Science and Technology of the Mining and Metallurgy – Kraków              1995 – 2002

•  M.Sc.  –  Metallurgy and Foundry Engineering

•  Topic Master’s thesis:   Measurement of heat effects during heat treatment of ADI

•  Equivalent to NFQ Level 9

Technical Secondary School of the Polish Natural Gas and Oil Industry – Kraków                   1991 – 1994

•  Leaving Certificate

•  Trade skills exam

•  Occupation:  Technician–Fitter of Installations and Devices of the Natural Gas Engineering Industry

•  Equivalent to NFQ Level 5

Electric Vocational School – Kraków                                                                                                      1987 – 1990

•  Trade skills exam

•  Occupation:   Fitter of Electronic Circuits and Electro-Mechanical Industrial Automatics

•  Equivalent to NFQ Level 4

 

Certificates And Qualifications

•  ECDL 5.0 Certificate (proficient in the use of Microsoft Excel, Word, PowerPoint, email and internet)

•  Level 5 Warehousing Certificate

•  Level 5 Counterbalance Fork Lift Truck Driving License

•  Jungheinrich Ride-on and Walked operated fork lift License

•  FAS Level 4 Manual Handling Certificate

•  FAS Safe Pass, Harness Training, Fire Extinguisher Training

•  Completed Grade A and Grade B sterile gowning training

Hobbies and Interests
•  Keeping physically fit, going to the gym, running, swimming and going to the cinema watching the latest           science fiction releases

  • Updated 4 years ago