Ramzi Shaheen

Experience

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  Bulleh Shah Packaging Pvt. Ltd. (BSP)

  Mar 2018 - Jul 2018

  Mechanical Maintenance Engineer

  Tasks:1- Diagnosing faults.2- Repairing equipment.3- Supervising technical staff.4- Responding to breakdowns.5- Creating maintenance procedures.6- Maintaining statistical and financial records.7- planning and undertaking scheduled maintenance.8- Obtaining specialist components, fixtures or fittings.9- Ensuring compliance with health and safety legislation.

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  Arab Potash Company

  Aug 2018 - Feb 2019

  Mechanical Maintenance Engineer

  The primary duty of this position is Monitor workflow of a CUTTER SUCTION DREDGER, which summarized as:1 - Monitor the operation & perform the periodic maintenance for diesel Engines (CAT 3516, CAT 3512 and two CAT C9 Generators).2 - Observe the operation of the Hydraulic system, which consists merely of (9 pumps attached to the gearbox of CAT 3512 diesel engine, 10 Hydraulic Winches mainly, two Hydraulic cranes for the Spuds, Hydraulic Spud Vector, and an emergency backup pump).3 - Supervising the Hydraulic team to carry out maintenance work and repairs required for breakdowns in the Hydraulic system.4 - Steering a team consists of a Mechanic, an industrial Blacksmith, and two Deckhands.5 - Making critical decisions in emergencies and doing the necessary work to resolve technical problems in a scientifically corrective way to prevent and minimize the losses.6 - Watch the SCADA system in the cockpit regularly and work to recognize any abnormal problem and diagnosis of bugs before the problem occurs entirely to ensure the workflow of Dredger without any interruption. Show less

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  Hikma Pharmaceuticals

  Jun 2019 - Jul 2023

  1- Co-ordinating/Directing & actively participating in the validation of site equipment, instruments, facilities, utilities, processes & automated & Computerized systems in compliance with company policies, regulatory requirements, & European cGMP & GAMP standards.2- Overseeing & solving qualification & validation execution issues using critical analysis skills & developing sound, reasoned solutions & recommendations.3- Finalizing site equipment, instruments, facilities, utilities, processes & automated & Computerized systems validation reports, coordinate documentation collection, & analyses collected data against pre-determined criteria.4- Performing &/or supervising risk assessments for site equipment, instruments, facilities, utilities, processes & automated & Computerized systems.5- Overseeing the review of old & new site equipment, instruments, facilities, utilities, processes & automated & Computerized systems assessment against the applicable regulations, i.e., 21 CFR part 11, data integrity policies, etc.6- Managing change control processes & representing the Validation in the Change Control committee, evaluating the impact of changes to the validated state, ensuring that they have been appropriately assessed & that validation strategy matches the risk identified.7- Providing the required information on relevant regulations & internal validation policy about equipment, instruments, facilities, utilities, processes & automated & Computerized systems.8- Generating, updating & reviewing validation plans/protocols/deliverables, SOPs, VMP, & qualification & re-qualification plans concerning pre-defined risk assessments.9- Participating in the User Requirements Specifications committee, providing the required information on relevant regulations & guidelines regarding any new system, actively participating through suppliers/manufacturer/service provider assessments/meetings, evaluating issues & developing solutions/recommendations using analytical skills. Show less A Production Engineer, mainly working on Takida Pharmaceutical products, where duties compiled as below:1 - Operating and observing the use of all machines & equipment related to the department of Solid products.2 - Develop all related manufacturing technical processes & identify opportunities for improvement to increase productivity while maintaining product quality.3 - Creating, improving & examining of Standard Operating Procedure SOP's & MO's to satisfy the best possible daily use. Show less

  • Validation Engineer

    Jan 2020 - Jul 2023

  • Production Engineer

    Jun 2019 - Dec 2019
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  Abbott

  Jun 2023 - Jun 2024

  Validation Engineer
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  SL Controls Ltd

  Jun 2023 - Jan 2025

  1- Validation Leadership: Direct the development, execution, and approval of Validation Master Plans, leading all validation and revalidation activities. Oversee the preparation, review, and approval of critical validation documents, including such as protocols, reports, risk assessments, and traceability matrices.2- Policy & Compliance Management: Spearhead the creation and continuous enhancement of validation policies and procedures, ensuring strict compliance with global standards. Conduct audits and internal quality reviews to proactively resolve compliance issues.3- Change & Risk Management: Manage change control processes and assess their impact on validation and compliance. Coordinate and manage comprehensive risk assessments for customer projects, ensuring risks are effectively identified, assessed and mitigated.4- Specification & Vendor Management: Evaluate and approve specifications for equipment, processes, products, and computerized systems, ensuring they meet validation requirements. Manage vendor validation documentation, ensuring external partners comply with organizational standards.5- Software Validation: Develop, review, and implement software validation plans and test protocols, focusing on embedded medical devices. Collaborate with software engineering teams to integrate validation principles throughout development.6- Team Leadership: Lead and mentor project teams, conducting performance evaluations and driving motivation to achieve peak performance. Identify training needs and foster continuous improvement in validation practices.7- Client Engagement: Work closely with the commercial department to explore new business opportunities and contribute to client proposals. Communicate project outcomes and progress effectively through presentations to stakeholders.8- On-Site Management: Maintain a strong on-site presence throughout project lifecycles, ensuring all validation activities are executed with precision and meet client expectations. Show less 1- Contributes to the preparation and review of the Validation Master Plan.2- Contributes to the development and maintenance of internal validation policies and procedures based on best international standards and practices.3- Contributes to the generation of all validation strategies and deliverables.4- Contributes to updates of existing quality documentation related to validation activities.5- Establishing, implementing and directing validation and revalidation activities.6- Troubleshooting validation issues associated with the validation project and provide feedback to the design team.7- Reviewing and approving specifications associated with Equipment, Processes, Products and Computerised Systems.8- Contributes to the design and implementation of software validation processes on projects.9- Conducts to routine Internal Quality Audits of the organisation to ensure compliance, be proactive in resolving issues which may arise.10- Understands and applies the industry specific standards/regulations.11- Manages multiple projects/activities independently using structured approaches.12- Co-ordinating the validation activities (including the vendors).13- Interacts with project team on overall project goals and as appropriate through the project lifecycle.14- Initiates and develops plans to ensure the timely completion of several projects/ assignments.15- Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process.16- Generating validation documentation including risk assessments, traceability matrices, and validation reports.17- Ensuring that all results and data are correct and following up and closing out any gaps or discrepancies.18- Conducts audits of internal projects against internal validation policies and procedures.19- Analysis and interpretation of data and test results.20- Participates in the development and review of software requirements. Show less

  • Senior Validation Engineer

    Jul 2024 - Jan 2025

  • Validation Engineer

    Jun 2023 - Jul 2024
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  Solventum

  May 2024 - now

  • Computer Systems Validation Lead

    Aug 2024 - now

  • Senior Computer System Validation Engineer

    May 2024 - Aug 2024
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  NNIT

  Jan 2025 - now

  Senior Validation Engineer