CHRISTEN FARAHAT
Middletown,DE
Summary
Process Engineer with 10+ years of experience supporting manufacturing, capital projects, and process scale-up in cGMP-regulated environments. Proven ability to lead cross-functional teams through engineering design, CQV activities (FAT/SAT, IQ/OQ/PQ), and manufacturing readiness. Strong expertise in process validation, risk management (FMEA), and technical documentation, with hands-on experience supporting engineering batches, PPQ, and commercial manufacturing. Demonstrated success in driving process improvements, leading hazard analyses, and supporting tech transfer and new introduction of product. Six Sigma Black Belt with a data-driven approach to root cause analysis, continuous improvement, and operational excellence.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Senior Formulation Process Engineer
AstraZeneca Pharmaceuticals
Newark, DE
11.2023 - Current
- Provide technical support to manufacturing and engineering teams supporting drug substance and product commercialization.
- Lead cross-functional execution of manufacturing readiness, including engineering runs, validation activities, and process performance qualification (PPQ).
- Support Commissioning & Qualification (CQV) activities including FAT, SAT, IQ/OQ, ensuring compliance with cGMP and validation standards.
- Drive risk-based approaches to manufacturing through Process Hazard Analyses (PHA) and Quality Risk Assessments (FMEA).
- Collaborate with engineering design firms and internal stakeholders on process and equipment design for manufacturing systems.
- Author and review technical documents including batch records, SOPs, validation protocols, and technical reports.
- Support automation and process improvements within manufacturing operations to enhance efficiency and robustness.
- Provide on-the-floor technical support during engineering batches, shakedown runs, and PPQ campaigns.
- Support deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA).
- Communicate complex technical issues and risks to leadership, stakeholders, and cross-functional teams.
Process Engineer
MATIV
Middletown, DE
01.2022 - 10.2023
- Communicate complex technical issues and risks to leadership, stakeholders, and cross-functional teams.
- Led capital and process improvement projects in regulated manufacturing environments, supporting equipment upgrades and process optimization.
- Managed FAT and SAT execution for new equipment, ensuring alignment with design specifications and operational requirements.
- Supported equipment qualification and validation activities, including IQ/OQ documentation and execution.
- Developed and standardized technical documentation, including SOPs, work instructions, and validation protocols.
- Performed root cause analysis and implemented data-driven continuous improvement initiatives to enhance process performance.
- Coordinated cross-functional teams (engineering, quality, operations) to ensure successful project execution and manufacturing readiness.
- Applied risk management tools (FMEA) to identify and mitigate process and equipment risks.
Field Service Engineer
Graver Technologies
Glasgow, DE
02.2021 - 12.2021
- Supported installation, commissioning, and troubleshooting of process equipment used in filtration and bioprocessing applications.
- Executed on-site SAT activities and ensured systems met operational and performance requirements.
- Authored technical documentation and training materials to support equipment operation and maintenance.
- Provided technical support to manufacturing teams, improving system reliability and performance.
- Trained operators and engineers on equipment functionality, safety, and process best practices.
Field Process Engineer
Sartorius Stedim North America
Wilmington, Delaware
04.2019 - 05.2020
- Supported bioprocess equipment implementation including filtration and single-use technologies relevant to drug substance manufacturing.
- Assisted with process optimization, troubleshooting, and scale-up activities for customer manufacturing processes.
- Collaborated with cross-functional teams to improve process efficiency and standardize operations.
- Conducted root cause investigations and supported continuous improvement initiatives.
Inside Technical Sales Engineer
SEW Eurodrive
Bridgeport
12.2014 - 04.2019
- Delivered engineering support to customers through detailed engineering drawings and product specifications.
- Generated 3D models and dimensional drawings for quotations and customer approvals.
- Monitored inventory using SAP/MRP to ensure optimal part availability.
- Collaborated with engineering teams to resolve complex service requests.
- Trained new staff in customer service protocols and technical solutions.
- Configured customer products in SAP based on technical specifications to identify cost-effective solutions.
- Fostered strong professional relationships with key accounts to support ongoing business growth.
- Educated customers on product installation and operation to maximize performance and longevity.
Engineer Intern
Orascom Construction Industries
04.2010 - 08.2010
- Preparing and documenting technical operating procedures, Manuals, and reports
- Checking and cross-referencing mechanical drawings and assisting in operations
- Monitoring installation and testing of industrial mechanical equipment.
- Understood and complied with safety regulations.
Engineer Intern
Sobhi Sanad Sons Service center
04.2008 - 08.2008
- Assisted in the improvement of processes and optimizing productivity.
- Created, analyzed, and applied original work measurements.
- Coordinated with cross-functional teams and resolved operational problems.
- Performed cost-benefit analysis on projects and validated the technical document.
Education
Bachelor of Science - Mechanical Engineering
Higher Technological Institute
10th of Ramadan City, Egypt08-2010
Skills
- Engineering Batches, PPQ & Commercial Manufacturing Support
- Tech Transfer & New Product Introduction (NPI)
- Troubleshooting and testing
- Regulatory compliance (FDA, cGMP)
- Problem solving (PPS, Level0)
- Process Hazard Analysis (PHA) & Quality Risk Management (FMEA)
- Commissioning, Qualification & Validation (CQV: FAT, SAT, IQ/OQ/PQ)
- Technical Documentation (Batch Records, SOPs, Technical Reports)
- Root Cause Analysis & Continuous Improvement (Six Sigma)
- Cross-Functional Leadership (Engineering, Quality, Manufacturing)
Certification
- CSSC Certified Six Sigma Black Belt
- Certificate of Completion of PMP Course
- Lean Leadership Training
- ISO 9001 Quality
- AI Bronze
Languages
English
Arabic
Timeline
Senior Formulation Process Engineer
AstraZeneca Pharmaceuticals
11.2023 - Current
Process Engineer
MATIV
01.2022 - 10.2023
Field Service Engineer
Graver Technologies
02.2021 - 12.2021
Field Process Engineer
Sartorius Stedim North America
04.2019 - 05.2020
Inside Technical Sales Engineer
SEW Eurodrive
12.2014 - 04.2019
Engineer Intern
Orascom Construction Industries
04.2010 - 08.2010
Engineer Intern
Sobhi Sanad Sons Service center
04.2008 - 08.2008
Bachelor of Science - Mechanical Engineering
Higher Technological Institute