Youssef Okaf
Uppsala
Summary
Seasoned CQC Lead CQV with a proven track record at Just Evotec, adept in overseeing comprehensive CQV deliverables and ensuring regulatory compliance, including FDA and EUMA regulations. Demonstrates expertise in production and manufacturing processes, underpinned by a strong foundation in quality principles and CGMP requirements. Excelled in enhancing operational efficiencies and maintaining high-quality standards, leveraging skills in DeltaV and KNEAT.
Overview
29
29
years of professional experience
1
1
Certification
Work History
CQC Lead CQV
Just Evotec
Toulouse
11.2023 - Current
- Company Overview: Toulouse Site, France, Bono Project SUS
- Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages
- Lead execution of all CQV deliverables; FAT/SAT/CTP/IOQ
- Liaise with CQV SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase
- Lead daily morning meeting to discuss and address log risk issues and rectify them
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all assigned Systems, ensuring all correct predecessors and successors are in place
- Ensure Commissioning readiness to support Equipment Start-up and IOQ Testing
- Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner
- Lead CQV review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise
- Liaise with CQV Document Generation Lead in relation to generation and approval of; DQ/Design Reviews URS, SRA, CRA /Test Matrices/Risk Assessments/QA Vendor Assessments/FAT/SAT/CTP/IOQ Protocols
- Run Weekly CQV Meeting and ensure updates are provided to Weekly CQV Meeting
- Toulouse Site, France, Bono Project SUS
Senior CQV Engineering
Eli Lilly
Cork
09.2022 - 11.2023
- Company Overview: Cork API Site, Cork County Ireland, TPWZ Project
- Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages
- Lead execution of all CQV deliverables (FAT, SAT, RV, IV, OV)
- Liaise with CQV SWAT Team in relation to punch list closure both pre-M/C and during the CQV execution phase
- Lead daily morning meeting to discuss and address log risk issues and rectify them
- Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all assigned Systems, ensuring all correct predecessors and successors are in place
- Ensure Commissioning readiness to support Equipment Start-up and IOV Testing
- Lead CQV review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise
- Vendor and Contractor coordination and supervision (offsite and onsite)
- Review and acceptance of contractor and vendor handover documentation
- Acceptance of systems at Mechanical Completion
- Safe energization and start-up of equipment and systems
- Participate in mechanical construction walk downs, C&Q to allow a smooth hand-over of Process Equipment’s
- Ensure the operation and the correct execution of all maintenance activities of the process equipment in compliance with Safety and cGMP requirements
- Coordinating the planning and scheduling of commissioning activities with HSE, Automation, Electrical, Instrumentation, Operation and Engineering
- Generate and Execute CQV activities Documents in KNEAT System
- Reporting and following up on deviations, solving technical problems
- Follow-up of changes via the applicable project change control procedure
- Cork API Site, Cork County Ireland, TPWZ Project
Project Lead
AstraZeneca
Stockholm
04.2021 - 08.2022
- Company Overview: Sweden Biologics Site, Stockholm County, Sweden
- Managed commissioning, qualifications and validations activities for the introduction of new product to fill finish production including filling line, media fill, visual inspection and packaging
- Drafted qualification and validations documents for testing, VMP, QP, IQ, OQ, PQ and risk assessments
- Review and approval for utility, equipment, and utility commissioning and qualification process validation, from both technical and compliance perspectives
- Ensured that all regulatory and cGMPs compliance items related to validation are satisfied and ensures Validation Master Plan (VMP) adherence
- Reviewed and approves executed qualification and validation documents associated with the qualifications and participate in resulting investigations and correction / corrective action planning
- Identified unresolved issues/decisions related to validation documents and coordinates resolution with other departments
- Worked with stakeholder to complete qualification and validation activities
- Sweden Biologics Site, Stockholm County, Sweden
Senior CQV Lead Engineering
Lonza
Visp
11.2019 - 04.2021
- Company Overview: Visp, Switzerland
- Coordinate commissioning and qualification engineers activities, personnel provided by contractors as well personnel from vendors of complex equipment / packages
- Generate and manage CQV documents
- Perform commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments
- Authors URS, FAT, SAT, DQ, IQ OQ TS SAT/COMM documents as well as protocols, initiates Controlled documentation in support of CQV projects
- Knowledge of commissioning and qualification requirements according to cGMP regulations
- Knowledge of Quality assurance principles and experience working with cross-department stakeholder
- Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests Equipment accurately to meet requirements for intended use
- Investigates failures and deviations; creates reports
- Analyses and reviews spare parts lists to ensure they are fit for purpose
- Reviews engineering drawings for accuracy and acts to correct errors
- Performs system walk-downs and makes changes using the change control of processes
- Initiates and resolves client Corrective and Preventative Actions (CAPAs)
- Visp, Switzerland
Cleaning Validation Engineering
Sanofi
Paris
05.2019 - 11.2019
- Company Overview: Paris, France
- Drafted cleaning validation protocols and final reports
- Performed cleaning validation protocols
- Reviewed cleaning validation documents
- Developed Cleaning Validation execution strategies that meet regulatory compliance
- Paris, France
Commissioning, Qualification and Validation Engineering
N.ovartis
Huningue
01.2019 - 05.2019
- Company Overview: Huningue, France
- Performed commissioning, qualification, and validation testing on manufacturing process equipment
- Authored protocols initiated controlled documentation in support of CQV projects
- Commissioning of equipment on site and all associated documentation check the pre-requisites
- Responsible for the validation steps and the review of C&Q documentation, track related incidents
- Responsible for follow-up Commissioning and Qualification activities and verify pre-requisites
- Commissioning execution and approval
- Includes vendor supervision on their testing scope and quality
- Installation Qualification execution and approval
- Including release for OQ
- Ensure respect of GMP, GDP and GEP during C&Q activities
- Participated in Gap Analysis and Risk Assessments
- Investigated failures and deviations as well as assist in execution of change control
- Huningue, France
Consultant Process Engineering
Valneva
Stockholm
01.2017 - 10.2017
- Company Overview: Stockholm, Sweden
- Provided technical, and general production support for the manufacturing operation
- Performed quality assurance tasks
- Monitored and trending of process data
- Executed validation and qualification protocols
- Stockholm, Sweden
Consultant Manufacturing and Quality Specialist
Biogen
Hillrod
06.2016 - 12.2016
- Company Overview: Hillrod, Denmark
- Provide QA review and disposition of commercial lots of drug substance, drug product and finished goods
- Provided technical and general production support for the manufacturing operations
- Performed and reviewed validation and qualification Protocols
- Monitor process operations to ensure compliance with specifications
- Collaborate with manufacturing and support teams to initiate and triage new deviation events, reviews manufacturing deviations
- Hillrod, Denmark
Research and Development Project Associate
Anocca AB
Stockholm
10.2015 - 05.2016
- Company Overview: Stockholm, Sweden
- Managed daily activities and process production workflows in the Bacterial Core Facility
- Reviewed all clinical trial and R&D documents according to GLP and GMP regulations
- Contributed to design process R &D documents, draft protocols and batch records for Bacterial Core Facility
- Responsible for updating and maintenance of DNA cloning vector database
- Stockholm, Sweden
Quality Assurance
Dilaforette Karolinska Institute
Stockholm
09.2014 - 09.2015
- Company Overview: Stockholm, Sweden
- Reviewed all clinical trial and R&D documents according to GLP and GMP regulations
- Reviewed production records and other GMP documents and reports
- Generated and/or reviewed deviations and investigations to assess cGMP compliance of lots
- Helped auditing cGMP manufacturing area
- Stockholm, Sweden
Downstream and Upstream, Process Engineer Associate
Genzyme Therapeutics
Allston
06.2008 - 06.2014
- Company Overview: Allston, MA, USA
- Managed, Processed and performed daily activities in the production
- Performed start up activities, commissioning, qualification and validation process for new production area
- Perform equipment qualifications including Commissioning, IQ, OQ and PQ
- Support performed and coordinated cleaning validation process
- Support auditing and prepared cGMP suite for inspection
- Operated and monitored upstream and downstream unit operations
- Ensured execution of duties, communicated at daily scheduling meetings, and provided technical support
- Supported process equipment maintenance team
- Gathered trends and analysed process-generated data
- Performed deviation initiation and closure CAPA, and change control
- Performed review and supported the creation of the batch record review, SOP, and work order generation
- Interacted with other support functions such as QA, QC, Manufacturing Engineering, and Validation
- Provided training to new personnel in a specific technical process
- Allston, MA, USA
Downstream, Process Engineer Associate
Amgen
West Greenwich
02.2006 - 05.2008
- Company Overview: West Greenwich, RI, USA
- Performed validation process and protocols
- Experienced with investigating production deviations and authoring deviation content
- Conducted cGMP document reviews and revisions including batch production records, and manufacturing procedures
- Monitored and troubleshoot of components and process equipment
- Experienced with lean management
- Processed, Operated large-scale unit operations in downstream
- Reviewed and analysed process trend for each unit operation
- Processed activities in business programs such as ERP, LIMS, Track wise, and Werum
- Provided training and operational guidance to other associates
- West Greenwich, RI, USA
Downstream, Manufacturing Associate
Lonza Biologics
Portsmouth
09.2004 - 01.2006
- Company Overview: Portsmouth, NH, USA
- Provided support for commissioning, qualification and validation activities
- Executed validation procedure IQs, OQs and PQs for equipment and process
- Experienced providing start-up support for new biologics manufacturing processes
- Operated all downstream unit operation for biologic productions
- Reviewed, authored, and improved manufacturing documents
- Assisted in inventory tracking equipment maintenance schedule
- Portsmouth, NH, USA
Research Associate
Whitehead Institute Center for Sequencing Human Genome
Cambridge
05.1998 - 05.2003
- Company Overview: Cambridge, MA, USA
- Managed daily activities and workflow process of large-scale vector DNA
- Processed and purified large scale vector DNA for genome sequencing
- Responsible executing plasmid extraction and cloning activities
- Responsible preparing batches of lawn cells, media, and solutions, plasmids, vectors and reagents
- Prepared reagents aliquots for use in a high throughput sequencing
- Monitored critical reagents inventory and records and tracks all quality control data
- Cambridge, MA, USA
Quality Control Associate
Genetic Institute
Andover
01.1996 - 04.1998
- Company Overview: Andover, MA, USA
- Responsible for testing stability of commercial dug products
- Performed analytical techniques such as coagulation, moisture and SDS-PAGE
- Run assays under Current Good Manufacture Practice guidelines and analysed data
- Andover, MA, USA
Education
Master Engineering - Chemical Engineering, Biotechnology Engineering
Tufts University, College of Engineering
Medford, MA, USA01.2004
Bachelor of Science - Electrical Engineering, Mathematics
University of Massachusetts, Lowell, College Of Engineering
Lowell, MA, USA01.1994
DEUG of Science - Physic, Mathematic, Chemistry
University of Hassan II, Faculty of Science
Casablanca, Morocco01.1988
Skills
- Regulatory Experience
- Knowledge of FDA regulations
- Knowledge of EUMA regulations
- Knowledge of drug substance and product
- Units operation
- Production and manufacturing process
- Quality principles
- CGMP requirements
- Proficient in Microsoft Office
- DeltaV
- Trackwise System
- ABB Process and Control System
- Minitab
- COMOS
- SABA
- Document Management System
- FirstDoct
- KNEAT
- PI
Certification
- Six Sigma and Lean: Quantitative Tools for Quality and Productivity, Technical University Munich School of Lean Production, 04/2018
- TUM Lean Six Sigma Yellow Belt, Technical University Munich, 04/2018
- Six sigma: Analyse, Improvement and Control, Technical University Munich, 12/2017
- Six Sigma: Define and Measure, Technical University Munich, 08/2017
- Leda och driva kvalitetsarbete, STF Ingenjörsutbildning, 05/2016
Languages
fluent, very good Knowledge, good Knowledge, good knowledge and completed SFI
Timeline
CQC Lead CQV
Just Evotec
11.2023 - Current
Senior CQV Engineering
Eli Lilly
09.2022 - 11.2023
Project Lead
AstraZeneca
04.2021 - 08.2022
Senior CQV Lead Engineering
Lonza
11.2019 - 04.2021
Cleaning Validation Engineering
Sanofi
05.2019 - 11.2019
Commissioning, Qualification and Validation Engineering
N.ovartis
01.2019 - 05.2019
Consultant Process Engineering
Valneva
01.2017 - 10.2017
Consultant Manufacturing and Quality Specialist
Biogen
06.2016 - 12.2016
Research and Development Project Associate
Anocca AB
10.2015 - 05.2016
Quality Assurance
Dilaforette Karolinska Institute
09.2014 - 09.2015
Downstream and Upstream, Process Engineer Associate
Genzyme Therapeutics
06.2008 - 06.2014
Downstream, Process Engineer Associate
Amgen
02.2006 - 05.2008
Downstream, Manufacturing Associate
Lonza Biologics
09.2004 - 01.2006
Research Associate
Whitehead Institute Center for Sequencing Human Genome
05.1998 - 05.2003
Quality Control Associate
Genetic Institute
01.1996 - 04.1998
Master Engineering - Chemical Engineering, Biotechnology Engineering
Tufts University, College of Engineering
Bachelor of Science - Electrical Engineering, Mathematics
University of Massachusetts, Lowell, College Of Engineering
DEUG of Science - Physic, Mathematic, Chemistry
University of Hassan II, Faculty of Science
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