LILITH WEEKS-YOUNG
Washington,DC
Summary
Project Engineer and Chemical Engineer with hands-on experience supporting commissioning, qualification, and validation (CQV/CSV) in GMP-regulated biotech and pharmaceutical environments. Known for owning equipment qualifications end-to-end, writing clear and compliant documentation, and working directly with clients and cross-functional teams to drive execution. Brings a thoughtful, quality-first approach and the professionalism needed to represent consulting teams in client-facing environments.
Overview
4
4
years of professional experience
Work History
Project Engineer – CQV Engineering
Project Farma
Rockville, MD
04.2025 - Current
- Support commissioning, qualification, and validation activities across CQV and CSV workstreams in GMP manufacturing environments.
- Author and execute qualification documentation including URSs, IOQs, PQs, and engineering changes in alignment with client SOPs and GMP requirements.
- Take ownership of equipment qualifications from planning through execution and closeout for a broad range of laboratory and manufacturing systems.
- Serve as a technical point of contact for systems such as BACT, xCELLigence, non-viable particle counters, CTUs, EMS/CDZ, QuantStudio 7 Pro, and label printers.
- Work closely with Quality, Manufacturing, Automation, Facilities, IT, and vendors to resolve execution challenges and maintain aggressive project timelines.
- Apply a root-cause-driven, quality-first approach to problem solving, balancing compliance expectations with practical execution needs.
- Support audit readiness by clearly explaining execution decisions, documentation strategy, and system functionality to clients and internal stakeholders.
- Review team deliverables and mentor newer team members, reinforcing strong documentation practices and GMP fundamentals.
- Maintain execution trackers and introduce visual management tools to improve team alignment, visibility, and follow-through.
Manufacturing Engineering Intern
Abbott
Plymouth, MN
05.2023 - 08.2023
- Provided engineering support for intralogistics system optimization and quality assurance.
- Assisted with process FMEA implementation, identifying failure modes in material conveyance and automated handling.
- Authored technical documents including SOPs, 5 validation protocols, and compliance reports.
- Diagnosed and repaired a critical chiller system, reducing operational downtime by 40% and restoring optimal manufacturing conditions.
Research Assistant
Howard University
Washington, DC
09.2021 - 05.2022
- Researched and proposed a microfluidic RT-PCR test system, reducing analysis time by 30% and simplifying lab processes for portable use.
- Documented research findings, aligning with regulatory and scientific best practices.
- Assisted in evaluating test methodologies for quality control and performance assessment.
Education
Bachelor of Science - Chemical Engineering
Howard University
Washington, DCSkills
- Quality & Validation: CQV / CSV, GMP compliance, commissioning, equipment qualification, URS, IOQ, PQ, change control, audit readiness
- Systems & Tools: BACT, xCELLigence, EMS/CDZ, CTUs, non-viable particle counters, QuantStudio 7 Pro, SOPs, validation protocols
- Consulting & Soft Skills: Client-facing communication, clear technical writing, ownership mindset, cross-functional collaboration, adaptability, mentoring
Timeline
Project Engineer – CQV Engineering
Project Farma
04.2025 - Current
Manufacturing Engineering Intern
Abbott
05.2023 - 08.2023
Research Assistant
Howard University
09.2021 - 05.2022
Bachelor of Science - Chemical Engineering
Howard University