Hamid Amellal

E-mail:ad4uoh@r.postjobfree.com Phone: 816-***-****

Summary:

•MBA/BS in Electrical Engineering with 19 years of engineering, PMO-Project management, Business System Analyst experience in the general manufacturing sector and biotech/pharma world using different management tools in the area of but not limited to Conceptual Analysis performance, estimating, scheduling, and budgeting, contract negotiating/vendor contract review.

•Provide technical engineering changes, deploy/implement/upgrade/maintain to existing equipment and support of internal manufacturing processes and packaging lines.

•10+ years of Full lifecycle of project implementation of MES/SAP/ECC/EWM system experience including but not limited to, Project and people Management, L1/L2/L3/L4/L5 Integration in the field of Analysis/Design/Build involving different stakeholders, Regression/System Integration/E2E/Dry Run/UAT testing to deployment and system implementation.

•Over 15 years of IT/Automation engineering team management to implementation/testing and install of several systems including Emerson MES DeltaV I/Os & Controls based, packaging lines, as well as integrators and vendor negotiations.

•10+ years of Medical Device and Equipment Engineering/project management/Validation experience for SCADA Systems (exp water purification, filers, Utility SCADA system, blenders, compactors), packaging, and process/automation equipment projects.

•Analyze Data, draw conclusions, write summary reports, bring issues to resolution, and propose solutions where appropriate.

•Perform ongoing investigations/CAPAs and write deviations when necessary. As well as FDA audits as a CSV subject matter expert at Abbott Labs.

•Strong Validation(IQ, OQ, PQ) and CSV engineering/management in Biotech/Pharma domain for process equipment, automation equipment, packaging lines, and utility rooms.

•Deployment/Implementation and project Management and working hand in hand with Solution Designer Optel Vision System, Systech, SCT Mobility/Edge Track for a Pfizer project

•5+ of hands-on experience with programming of custom software, PLC/DCS/HMI.

• 7+ years’ experience with sterile aseptic manufacturing unit operations like granulation, coating, compounding, batching, mixing, cleaning, blending, freeze drying, SIP, filling, and packaging (Abbott, Ben Venue, 3M. Catalent, Patheon, Pfizer, Sanofi)

Behavioral Skills:

•Innovation - Effective Communication -Strategic Orientation- Client Focus -Managing Change- Execution Excellence -Managing Teams -Build Collaborative Relations

•Fluency with excellent communication skills in 3 languages; English, Arabic and French.

EDUCATION

•June 1994 - Bachelor of Science in Electrical Engineering

University of Massachusetts – Lowell, MA

•MBA at University of Miramar California

Expected graduation date MAY 2024

COMPUTER SKILLS

•Operating Systems: Windows, OS/2, SunOS, HP UNIX, ALPHA,

•Programming Languages: RSLogix 5000 enterprise, Siemens PLC SIMATIC, HMI, S5/S7, Data structure and C, C++, JAVA, UNIX Shell, FORTRAN, Assembly.

•Networking: PLC Frame/BUS network, TCP/IP, IPX/SPX, DECnet, LAT, ATM & FR

EXPERIENCES

Cognizant DEC 2018-Present

Senior Manager II, Team Management, Projects Deployment/Implementation

WestRock Corp

Manufacturing Senior Manager/Assistant Director (Consultant) Feb 23 to Present

•Conduct complete study of systems, processes, and personnel in a manufacturing centric environment in accordance to the Capabilities put forward by the business and learned through interviews of business and technical personnel by visiting four cartening equipment manufucturing sites; two in the US, one in England, and one in France.

•Define the functional and technical gaps standing in front of achieving the enterprise goal to double sales and enhance the business.

•Draw all Roadmaps of current state and propose future states based on the KPIs.

•Present solution based on the created future states for business processes and systems to be used including SAP/EWM MES systems, PLM and ERP integration, Salesforce, Maintenance system, Service systems etc

Bausch

Senior Systems/Automation Manager (Consultant) DEC22-Sep23

Work as senior manager to manage and implement all milestones and tasks for a Syncade Emerson EWM/MES system and integrated Delva V Automation controls and I/Os.

Made sure all requirements are met through SPEC traceability and verification/validation

Followed with EWM and MES and automation developers and sites to make sure all requirements are covered including recipes development, gathering of equipment DeltaV automation tags, etc

Full study of Rockwell automation systems for equipment and adopting the SCADA system to integrate better with the MES system

Work with business and site to understand the process needs to make sure recipes are developed to accuracy.

Implement LabVantage GLIMS system with different modules for different sites world wide

Modules implemented include Raw Material, Finished Goods, Stability, Environment Monitoring,

Managed and supervised a team of over 50 personnel of engineers, validation specialist, SMEs, end users involved in preparing User requirement, system specifications, SAP interfaces development, data migration, validation team, training material and users training

Cognizant/3M Senior Team&Project Manager (Oct 2020-Dec2022)

PMO in charge of deploying/implementing SAP/EWM MES system integration with S4 modules for different 3M sites

In charge of the formation of a “core solution group” at the start of the 3M deployment program with inputs from various production sites.

Managed a team of engineers to provide L2/L3 Integration solution to several 3M sites of 3M MES from current state to streaming a solution future states of the manufacturing systems.

Looking into all Rockwell automation system and reading all tags to build the integration wit the MES sytem.

In charge of orchestrating a team that understands the responsibility and accountability for designing and building the best MES solution that can be used at multiple 3M sites.

PMO in charge of ERP to EMS and PLM to EMS integration by assigning team responsibilities and keep track of project schedule to make sure nothing falls behind. Make sure that all hardware and software are functioning properly in conjunction with Databases.

Cognizant/Pfizer Senior Project Manager (AUG 2019- Oct 2020)

Senior manager in charge of deploying/implementing L3 solution of serialization systems; EdgeTrack and Optel as one of the serialization solutions for the Global Pfizer network in a sterile environment.

In charge of L2 software solution support for packaging lines and work hand in hand with Optel engineering team and packaging line SME to support the overall serialization solution and deployment.

Make sure all manufacturing compliance requirements are met and ensure the system (including GUI and Hand Hold applications such as Tracelink/EdgeTrack) are validated accordingly (CSV) in accordance with FDA regulatory.

Main liaison between Optel Solutions and Trace Link/EdgeTrack/SCT Mobility vendors and Pfizer business and technical groups.

Run extensive pilot testing for the EMS system which included several Pfizer sites within the US and abroad before production implementation.

Supervise the implementation/upgrade of Optel OSM/LineMaster sterilization system for several sites.

Cognizant/Sanofi Senior project manager (DEC 2018 to AUG 2019)

In charge of Deploying/implementing an Antares solution for a serialization project at Sanofi, Taylor PA

Develop engineering documents such as URS, DDS, FAT, SAT, commissioning and maintenance plans.

Deploy Antares system as a serialization solution for packaging and Distributing Sanofi products worldwide for the Taylor, PA site.

Make sure all network hardware/automation equipment including switches, Antares servers and software configuration, Firewall rules, are implemented according to FDA regulations and in compliance.

Ensure MES is configured to accommodate business need to keep track of the manufacturing execution including vendors/solution providers, electricians to equipment housing cabinets’ manufacturers to insure solutions are provided in a timely manner and in accordance to contracts/POs.

Ensure all automation/process equipment under the MES system supervisory deployed for the solution are in compliance with FDA regulations.

AutomaElec Inc.,

Casablanca, Morocco/France NOV 2016 to SEP 2018

Assistant Director

Senior FDA Regulations advisor to AutomaElec a French/Moroccan company interested in starting Automation projects for Biotech/Pharma companies in the states.

Technical advisor to the engineering director on several CAPEX projects and technical aid to the sales department.

Formed an FDA department responsible for FDA regulations, technical documentation, and staff training for the company.

Look into MES systems advantage for biotech/pharma companies and understand what are the needs for the AutoaElec team to learn and get familiar with to be able to implement and interface to MES system.

Review and approve work in a timely manner and designate a stakeholder from customer end who would provide formal acceptance testing of work products.

Train engineering personnel on documents development such as URS, DDS, FAT, SAT, commissioning and maintenance plan/documents during system and new equipment purchase/ install.

BWDesign Group

Team & Project Manager (Significant project for Pfizer/Hospira) OCT 2015- OCT 2016

Responsibilities include all aspects of project excursion including design, procurement, layout, contractor management, OEMs, and install of a serialization system for 14 production lines.

Develop engineering project documents; URS, DDS, SAT, FAT, Operation, maintenance, and training documents

Work hand in hand with solution designers, OEM for integration work, general contractors (electrical and mechanical) to drive the project to a conclusion and on schedule.

Serialization platform:Optel Vision system LineMaster/Pharmaproof technology with Systech technology.

Ability to build and lead a team for deployment, upgrade and support activities for Systech product/vision systems of pharma manufacturing lines and work hand in hand with Optel,Systech, and other OEMs.

CGMP Engineering/Catalent Kansas City 2013 to 2015

Senior Manager/Project Engineer Manager (Catalent Consultant)

Successfully managed a high dollar project to install and validate the process equipment, facility and Utility side of a newly built Catalent facility in Kansas City where the first Pharmacyclics and J&J Imbruvica (Ibrutinib 140mg) drug will be manufactured.

Validate the Rockwell automation system integration for Eli Lilly equipment in Kansas city

Equipment list: IBC Washer/Dryer, Downflow Booth, Drum Tipper/Drum Mover/Scales, Alexanderwerk Vibratory Screener, Alexanderwerk Roller Compactor, OptelVision System, Bosch Weighing sorter, MG2 Encapsulator with a NETT control system with metal detector and dust collector, Fitzpatrick Mills, IBC Blenders, Several Charging station, Flexible Containment Isolator systems, Utility Nitrogen system, USP water, Warehouse/Vault storage facilities temperature and humidity mapping, Building Environment baseline study, Facility IQ and Facility controls IOQ

Patheon Pharmaceutical, Cincinnati OH October 2011 to Nov 2012

Senior Process Controls Engineer/Project manager

Project managing the improvement of the Coating and Granulation side of Patheon Cincinnati site including recipe updates.

Developed a CAPEX project plan/review vendor project plans/ negotiated contract to determine best vendor for the project (Moving the obsolete APACS system to a Rockwell based system)

Work as the liaison and project coordinator between Patheon high management and Rockwell and other contractors.

Provide a profound study to high management to make a smooth move from the APACS system to Rockwell based system to minimize production impact

Work as a team player in a group of engineers and process pharmacists to enhance the current coating and granulation process by doing control change, testing and validation

Manager a rigorous schedule to maintain equipment, upgrade, validate, and insurance a low to no down time.

Target Distribution Centers, Topeka, KS June 2006 to Sep. 2011

Automation/Control Systems Manager

Manage department budgets to run several projects at the corporate level and manage vendor partnership to keep projects under schedule.

Improve the design and quality of computer based data acquisition and control system

Oversee and supervise over 20 technicians to maintain the stability and maximize system throughput The system is a mix of 17 cranes/robots, PLC, pneumatic, mechanical (conveyor systems and sorting system), proximity switches, photo eyes, SICK and axiom scanners.

Implemented a sophisticated substation system through IDE (Intelligent Electronic Devices) Relays to manage distribution over all VAR consumption and improve maintenance.

Work with vendors, Operations, HQ personnel, contractors of several backgrounds to enhance/maintain/and improve the automation system and meet project deadlines

QVM Services, Kansas City, MO May 2005 to June 2006

Senior Equipment/Project Manager

Responsible for contacting companies to outsource work(/present estimates/proposals) and interacting with contractors on project by project basis for all QVM clients

Developed Validation Master plan for a Robotic Auto haler Assembly Machine (RAAM) for 3M Pharmaceutical, CA. The RAAM came as a replacement to the Maxair Auto haler Manual Assembly Table. The RAAM consists of Robotic Arms, Vision System, Control System PLC & HMI

Verified all wiring and drawings of the RAAM as part of the FAT.

Managed the process and the commissioning engineering team while executing upgrade/stability tests of medical devices equipment

Responsible for the stability, upgrade and management of all Data Communication equipment, telecommunication equipment, Communication Systems and their software applications, and DataBases and relevant databases applications.

Responsible for the design, procurement, documentation, commissioning and validation of process controlled pharmaceutical/biotechnical equipment for all QVM clients.

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