MOHAMMED ALKHAWAJAH
Houston
Summary
Results-driven Biomedical Engineer with expertise in GMP manufacturing, quality assurance, and process optimization within the biotech and pharmaceutical industries. Skilled in data analysis, problem-solving, and regulatory compliance (FDA, ISO, cGMP) with a strong background in validation, risk assessment, and process improvement. Experienced in cross-functional collaboration and leading quality initiatives to enhance operational efficiency. Eager to apply analytical thinking and structured problem-solving to drive impactful solutions in life sciences, healthcare, and operations.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Quality Assurance Validation Engineer
Lonza
10.2023 - Current
- Lead validation and qualification activities (IOPQ, IQ, OQ, PQ) for equipment and cleanroom operations, ensuring GMP compliance.
- Conduct root cause analysis CAPA investigations, addressing deviations and improving manufacturing processes.
- Review and approve validation protocols, SOPs, and regulatory documentation to maintain industry compliance.
- Collaborate with engineering, manufacturing, and regulatory teams to optimize processes and resolve quality issues.
- Conduct internal and external audits to ensure compliance with FDA, ISO, and company policies.
Viral Vector Core Technician Specialist
Lonza Biologics
09.2020 - 10.2023
- Performed aseptic techniques and cleanroom operations to support viral vector manufacturing in an ISO-classified environment.
- Conducted environmental monitoring (EM) activities, including viable/non-viable air sampling, surface testing, personnel monitoring, and microbial identification to ensure sterility in production areas.
- Managed cell culture, viral vector purification, and process troubleshooting for gene therapy products.
- Assisted in technology transfer and scale-up of viral vector production processes.
- Performed media fills, sterility assurance testing, and contamination control to meet quality standards.
- Maintained GMP documentation, batch records, and compliance with FDA, ISO, and company SOPs.
- Collaborated with QA and QC teams to address environmental monitoring deviations and implement corrective actions.
Quality Assurance Specialist
PharMEDium
01.2020 - 05.2020
- Conducted quality control and microbiological testing in cleanroom environments to ensure compliance with cGMP and DEA regulations.
- Identified product defects, performed root cause assessments, and supported OOS/deviation investigations.
- Executed validation and qualification of test methods, ensuring accuracy in clinical and commercial-grade product testing.
- Managed sample preparation, documentation, and submission to contract laboratories for external testing.
- Performed SAP transactions for material testing and release, supporting efficient inventory and compliance management.
- Maintained laboratory operations, including equipment maintenance, housekeeping, and supply management.
Medical Case Coordinator
Aqrawi And Associates PLLC
11.2018 - 05.2019
- Reviewed and interpreted medical records, radiology reports (CT scans, MRIs), and treatment summaries, translating them into legally relevant content for case preparation.
- Coordinated with medical providers to track patient treatments, obtain necessary documentation, and ensure compliance with legal case requirements.
- Served as the primary liaison between legal teams and healthcare providers, facilitating communication and securing medical evidence to support claims.
- Analyzed medical coding and billing information to assist attorneys in evaluating case value and settlement demands.
- Ensured accuracy and completeness of medical documentation, maintaining compliance with HIPAA and legal confidentiality standards.
- Assisted in case preparation, providing attorneys with organized medical records and supporting materials for negotiations and litigation.
Education
Bachelor of Science - Biomedical Engineering
University of Houston
Houston, TX05-2020
Skills
- GMP Manufacturing Expertise
- Validation & Qualification (IQ/OQ/PQ, IOPQ, DQ)
- Aseptic Processing Expertise
- Environmental Monitoring
- Risk Assessment and CAPA Analysis
- Process Optimization Expertise
- Sterility Assurance Practices
- Supply Chain Management
- Audit Documentation Management
- Data-Driven Analysis
- SPC and RCA Implementation Skills
- SQL, MATLAB, SAP, LIMS, TrackWise
- Skilled in Microsoft Office Suite Tools
- Automation Optimization
- Problem-Solving & Critical Thinking
- Strategic Process Improvement & Lean Six Sigma
Certification
- Data Analytics Foundation – Google
Issued Sep 2022 | Credential ID: WAUKS25R6GTV
Timeline
Quality Assurance Validation Engineer
Lonza
10.2023 - Current
Viral Vector Core Technician Specialist
Lonza Biologics
09.2020 - 10.2023
Quality Assurance Specialist
PharMEDium
01.2020 - 05.2020
Medical Case Coordinator
Aqrawi And Associates PLLC
11.2018 - 05.2019
- Data Analytics Foundation – Google
Issued Sep 2022 | Credential ID: WAUKS25R6GTV
Bachelor of Science - Biomedical Engineering
University of Houston
Similar Profiles
Preeti KapasiPreeti Kapasi
Marketing Automation Manager at LonzaMarketing Automation Manager at Lonza
Kamarah ClayKamarah Clay
Core Technician at LonzaCore Technician at Lonza
DIMITRIOS KOLIORADAKISDIMITRIOS KOLIORADAKIS
Research Analytical Scientst at LonzaResearch Analytical Scientst at Lonza