1. !Postal Address Visiting Address E-mail Phone
Approval Engineering AB info@approval.se 08 - 658 41 40
Box 14 Linjalvägen 6B
SE-183 21 TÄBY, SWEDEN SE-187 66 TÄBY www.approval.se
CV Aref Eyad Page 1 of 3
Curriculum Vitae (2016)
Aref Eyad
Profession Projec t & Validation Manager, Mechanical Engineer.
A total experience of 34 years as Consultant in Mechanical Engineering attached with industrial projects. Has
extensive experience of 28 years in the pharmaceutical industry CAPA, process / equipment validation and CC /
deviation handling with a strong background in process design of pipes, tanks, filling stations and HVAC systems.
Good communication skills and applies Lean Management.
Language Proficiency
Swedish and English (FCE, First Certificate in English by Cambridge University).
Key qualifications
Expert in Sterilization Validation using own Kaye Validator 2000.
Current assignments
Senior Project and Validation Manager within the Pharmaceutical and the Biopharmaceutical industry.
Education
M.Sc. in mechanical engineering. The Royal Institute of Technology (KTH) in Stockholm, Sweden.
Additional courses attached to Pharmaceutical Qualifications:
GMP repetition Courses.
Complying with 21 CFR Part 11- Electronic Signatures and Records,ISPE.
FDA Inspection Course.
GMP Compliance.
Validation Requirements and Practices.
GMP Validation requirements.
Training on Kaye Validator 2000 and Software.
Sterilization of Autoclaves.
GMP & Change Control for Pharmaceutical production.
Validation of Autoclaves.
Deviation Control within production & lab work, Pharmaceutical Plant.

2. !Postal Address Visiting Address E-mail Phone
Approval Engineering AB info@approval.se 08 - 658 41 40
Box 14 Linjalvägen 6B
SE-183 21 TÄBY, SWEDEN SE-187 66 TÄBY www.approval.se
CV Aref Eyad Page 2 of 3
Experience record
1988 -
Project & Validation Manager, Approval Engineering AB, Stockholm, SWEDEN.
Process, HVAC and Validation Engineering within Pharmaceutical plants.
1984 - 1988
Project engineer at Pharmacia AB, Uppsala.
Process, HVAC and Clean Room engineering.
1981 - 1984
Mechanical Engineer, Technical department, Bengt Dahlgren AB, Stockholm.
Experience summary
Design and Validation experience including management of many projects within Life Science.
Project range include; Terminal Sterilization (steam, gas, and radiation), Large and Small Volume
Parenterals, Bulk, API, Blow-Fill-Seal Validation, Vial filling validation, Dry products processing and
filling, Medical device product and process validation, Product Validation of Pre-filled syringes (USP),
CIP/SIP system, Classified rooms, Validation of various Medical Devices. In these capacities he has
prepared detailed Validation Master Plans, IQ, OQ, and PQ (s) for many pharmaceutical, API and
medical device processes.
Extract, Customers
Valneva Sweden AB, Sterisol AB, Crucell AB (SBL), Recipharm K-skoga AB, Cobra Biologics AB,
Oasmia AB, S:t Görans Hospital. Dental Services companies, Recipharm S-tälje AB, Pfizer
Strängnäs, SentoClone AB, Recip AB, Biovitrum AB, Aga Linde AB, Approval AB, CCS AB,
AstraZeneca AB, Biovitrum AB, Medicago AB, Octapharma AB, Pharmacia AB, Bohus Biotech AB,
Fresenius Kabi AB, Amersham Biosiences AB, Kemwell Biopharma AB, Biacore AB, Q-med AB
Extract, Experience records (Design, Validation or Project Management)
Validation of Decontamination Process for Vaccines
New Purified Water (PW) system,
Cold Storage Rooms for Vaccines
Modification Sterilization process, existing product
New Sterilization Process, new product
Design & Validation of CIP/SIP systems.
Freeze Drying process, Freeze Dryer Sterilization
New Cold Storage Room and new Freezers
New Sterile Liquidized Nitrogen Equipment
New Thermal Qualification Equipment
New BFS machines
GMP Review Process Equipment FDA inspection
Establishment of New GMP Quality System
New Production Line Sterile Manufacturing
New R&D Facility
New Laboratory Facility, Process Equipment
Revalidation of Process Equipment
Validation & Revalidation of Autoclaves, Tunnels, Tanks, Freeze Dryers
New Production Facility, Syringe Center
New Filling Line, Turbo haler
Updating Production Facility, API
New Utility distribution system

3. !Postal Address Visiting Address E-mail Phone
Approval Engineering AB info@approval.se 08 - 658 41 40
Box 14 Linjalvägen 6B
SE-183 21 TÄBY, SWEDEN SE-187 66 TÄBY www.approval.se
CV Aref Eyad Page 3 of 3
Dry Heat Sterilizers
New Tablet manufacturing Facility, Nexium IV
GMP Validation Review, process equipment
Evaluation of Parametric Release, Sterilization Process
Audit Sterile Manufacturing process
New Thermal Qualification Device
Calibration of Flow meters
Upgrade filtration line, Intralipid
English Translation of Validation Documentation
New Critical Clean Utility distribution systems
Increasing manufacturing capacity API
New WFI system
Increasing Cooling Capacity process lines
Audit HVAC / Clean Rooms installation
New Pure Steam Generator
New Fire Sprinkler system
3D visualization WFI system
New facility, Intralipid manufacturing
New API facility
Technical Standard process equipment
Supply lines Liquid & dry powder process
New Fluid Bed
Process upgrade, High-Shear Mixer, Tablet Pressing, Tablet Coating
New Stream Line filter
New laboratory facility including equipment, HEPA, LAF
Smoke visualization studies Clean Room
Excipient GMP upgrade manufacturing facility
New Bio-bed process for Waste Water
Upgrade Blister packaging, Sterile production
Storage tanks and distribution system chemical "Solvents"
New Radio analysis laboratory