Validation Engineer Process

Aziza Akbari

720-***-**** *****.******.**@*****.*** US LinkedIn: Aziza Akbari

OVERVIEW

A highly versatile and results-driven Process and Validation Engineer with extensive experience in manufacturing Site in the USA. Adept at ensuring product quality, optimizing processes, and driving continuous improvements. Proven expertise in validation techniques, regulatory compliance, and troubleshooting across various industries.

In addition to engineering expertise, I bring strong leadership and training skills as a Deputy Director and Senior English Instructor. With a background in program management, curriculum development, and instructional training, I have successfully partnered with organizations, universities, and educational institutions in Afghanistan, Pakistan and Indonesia.

Combining technical proficiency with a passion for education and training, I thrive in collaborative environments, ensuring both operational excellence and the development of skills in diverse teams.

EXPERTISE

Process Optimization Process Control Change Control Continuous Improvement ISO MS Project

PROFESSIONAL EXPERIENCE

Active Pharmaceutical Ingredients (API) Validation Engineer

Pfizer Kalamazoo, MI February 2024 – Present

Validation Engineer – Cleaning and Process Validation

Develop documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance, including process validation protocols and reports, cleaning validation protocols and reports, and cleaning records.

Optimize current cleaning procedures through improved solubility based on cleaning solvents used, use of cleaning detergents such as methanol and acetone, recycle times, and historical trending.

Determine impact of processing deviations to cleaning and process validation.

Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures.

Inspection and Swabbing Tanks and Filters for quality assurance and contamination control.

Process Engineer

Pfizer Kalamazoo, MI April 2023 – February 2024

Process engineer – Aseptic operations preparations

Integral member of the safety team, leading 5+ safety projects, and safety walks to identify and address areas of improvement in the production process, ensuring a secure work environment.

led comprehensive compliance training for a team of 20+ to ensure operational compliance.

Collaborated closely with the Kalamazoo Incoming Quality team, Validation and Procurement to meticulously research and successfully implement strategic changes directed by the supply chain.

Initiated quality improvement efforts that reduced deviations rates by 50% in key manufacturing process.

Deputy Director

Kara development network Kabul, Afghanistan 2020 – 2021

Optimize operational systems, processes and policies, management reporting to ensure a productive workplace.

Supports creation of financial reports and projects budgets as required.

Contributes to short and long-term strategic planning.

Assists with responding to grant proposals.

Serves as a link between the organization and Neighbor Works.

Directs staff on agency compliance with all contracts and relationships.

Cultural Navigator

Diversified Consultancy Colorado, USA 2023

Served as a key liaison between diverse cultural groups, promoting understanding and effective communication between individuals from different backgrounds.

Guided individuals and groups through cultural nuances, helping to overcome language barriers and facilitating cross-cultural interactions.

Developed and led cultural competency training sessions, improving cultural awareness for employees and clients.

Supported clients in navigating cultural differences, ensuring smoother transitions in educational, professional, or personal environments.

Coordinated community outreach programs to engage underrepresented populations and increase cultural inclusion.

Offered personalized consultation services to assist clients with cultural adaptation, focusing on areas like communication styles, social etiquette, and professional expectations.

EDUCATION

MBA Universitas Diponegoro, Semarang, Indonesia

Bachelor of Chemical Engineering Kabul Poly Technic University, Kabul, Afghanistan

COMMUNITY OUTREACH

Humanitarian Projects and Seminars on Peace, Empowerment, and Education Kabul, Afghanistan and Quetta, Pakistan

Organized and led seminars focusing on peace-building, women empowerment, and children’s empowerment, targeting diverse communities in Afghanistan and Pakistan.

Delivered educational content and facilitated discussions on social justice, gender equality, and the importance of peace, reaching over 1000 individuals, including community leaders, local organizations, and students.

Collaborated with NGOs, local governments, and educational institutions to design impactful programs that promoted social change and personal development.

Provided training and mentorship to women and children, helping them gain skills for personal and professional growth, fostering resilience and confidence.

Developed culturally sensitive materials and resources to ensure engagement and understanding, aligning with the local community’s values and needs.

Key Achievements:

Successfully implemented Peace Seminar, which reached around 500 people in Afghanistan and Pakistan, significantly improving awareness and participation in empowerment programs.

Helped build local networks of support for women and children, strengthening communities and creating a lasting impact on regional development efforts.

AWARDS AND ACHIEVEMENTS

Darmasiswa scholarship program (Bahasa Indonesia certificate)

IKIP Budi Utomo Malang institute

2019/2020

Youth Ambassador for Peace Certificate

Universal Peace Federation

2021

Peace Designer Training Certificate

IAYSP Europe and Middle East

2022

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