Bioprocess Engineer
National Institute for Bioprocessing Research & Training
مجموع سنوات الخبرة :14 years, 5 أشهر
• Aseptic transfer process techniques, Protection of sterile product from microorganism in the environment,
• Use of Laminar flow hood and writing SOP for Aseptic transfer, Proficient in cGMP regulations.
• Cell Culture, Contamination Control and monitoring of environment, Sanitisation procedures
• Cells analysis, Cells count using haemocytometyer and comparison with that of automated analyser (Vi-CELL), Metabolites analysis using Nova Bioprofile 400 analyser and use of Disposable technologies
• Familiar with connections required for stainless steel bioreactor changeover, cleaning-in-place (CIP)/Clean out of place (COP) and steam-in-place (SIP), perform coverage testing on a vessel and thermal mapping of a vessel, Tube welder and Tube sealer
• Commissioning, Validation and qualification, Centrifugation, Filter integrity, Troubleshooting using P&ID, Turbidity measurement, Column Packing and Column efficiency, Ultrafiltration/Diafiltration
• Bio-separation Protein purification techniques (Cell harvest, Filtration, Viral Clearance, Chromatography Technique Fill Finish and Formulations)
• Operational Excellence in Biopharmaceutical (Lean, Six Sigma, Continuous Improvement, 5S, Quality Auditing )
Design of experiment using statistical tools such as minitab, SPSS, LIMS, Qualification and Calibration.
Team responsible for Characterisation of API and Excipient of materials using microscopic imaging, Particle Analyser, Raman Analysis, NIR, Rheometry Analysis, Thermogravimetric Analysis, FTIR.
Blend uniformity using UV/Vis Spectroscopy, IR Spectroscopy, Rheometry Analysis, Thermogravimetric.
Tablet Testing (Finished Dose) such as friability, hardness, testing, Disintegration testing, Dissolution testing, Raman analysis and IR Analysis, validation and qualification (FDA & ICH Q8, Q9 & Q10).
Isolation and Purification of Catalase using chromatography method.
Lean Six Sigma, 5S project, FMEA analysis and CAPA analysis project, and Quality Auditing.
Responsible for carrying out checks on products and processes to ensure they met standards.
Prepared products for dispatch, ensuring clear labelling and accurately placed on boxes for customers.
Worked productively in a busy environment, helping out the rest of the team, meeting challenges proactively and ensuring that all quality standards were correctly maintained.
Carried out data input on a regular basis and ensured that the database was maintained accurately.
Complied with health and safety and quality procedures, policies and standards.
§ Experienced in cutting and joining composite materials including plastics using specialist welding methods and techniques
§ Demonstrated practical and creative thinking skills, the ability to solve problems as they arose and using own initiative to make quick decisions when dealing with unexpected situations
§ Exhibited good concentration levels, hand-to-eye coordination and good level of fitness
• Managed tracking of various forms of documentation from the preparation stage to the pre-approval and approval stages.
• Keeping the Validation document Register and Validation Logbook up to date.
• Liaising with the production department, Quality Assurance and quality control to make sure each batch is produced according to regulations before the next stage
• Ensured that Validation protocols complied with cGMP and that necessary documentation was completed in an accurate and timely manner and setting standard for quality as well as safety.
• Ensures that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Carry out analysis of materials using HPLC, UV Spectrometry, IR Spectrophotometry, testing water for production, and analysing component, raw materials (Compressibility and permeability), testing of finished drugs (Hardness of tablets, dissolution test, disintegration test, friability test, weight variation).
• Developing knowledge of current and emerging guidelines and regulatory strategies such as GMP and ICH guidelines, Quality by Designs and carrying out routine instrument calibration checks.
• Conducts laboratory investigations and generates reports in response to invalid assays, deviations, OOS/OOT making sure that manufacturing or production processes meet international and national standards looking at ways to reduce waste and increase efficiency.
• Execute instrumentation operations and performance qualification.
• Carried out small scale laboratory experiment before scale up in the plant.
• Carried out particle size distribution tests (PSD) using Malvern particle Size analyser.
• Carried out long term stability studies to establish the shelf life and quality of the finished products.
• Carried out reviewing documentation associated with batch release to ensure GMP compliance and ensuring the follow-up of the necessary corrective actions & preventative actions implemented
• Actively presented weekly summaries to colleagues and Manager.
Carried out daily administrative duties such as keeping the Validation document Register and validation Logbook up to date.
Managed tracking of various forms of documentation from the preparation stage to the pre-approval and approval stages
Identify and implement process, productivity & equipment utilisation improvements.
Execute instrumentation operations and performance qualification.
Application compilation and verification of summited documents
Compilation of approved list of successful candidate
Verification of successful candidate account details
Issuing payment to successful candidate and dealing with complains and investigations
Services and products sales daily account compilation
Account details reconciliation and forwarded to the account department
Dealing with customer’s orders, complains and poultry feed inspections from suppliers
Bioprocessing Principle Animal Cell culturing, Contamination Prevention. Operational Excellence
MSc: Pharmaceutical & Process Technology Subjects include: • Advanced Statistics (Design of Experiment), Bio and Pharmaceutical Transfer Technology, Management and Quality System, Advanced Project (Testing of raw Materials, In–process Uniformity, and finished product), Project Management, Technology Transfer, International Quality System (ISO 9001, 13485, and FDA), Risk Management, 5S and Lean Six Sigma, Quality management • Completed 8 hours laboratory analysis and documentation weekly