Title: Validation Engineer / CQV Engineer – Junior to Mid-Level
Location: Boston, MA – 100% Onsite
Duration: 12 Months (W2 Contract)
Position Overview
Our client is seeking 4–5 Junior to Mid-Level CQV/Validation Engineers to support a major pharmaceutical and cell therapy manufacturing project in Boston. These engineers will support commissioning, qualification, and validation activities for GMP manufacturing facilities, utilities, process equipment, and regulated systems.
Experience Levels
- Junior Validation Engineer: 1–3 years of U.S. validation experience
- Mid-Level Validation Engineer: 4–6 years of U.S. validation experience
Key Responsibilities
- Execute commissioning, qualification, and validation activities for GMP utilities, facilities, process equipment, and analytical systems.
- Support qualification of manufacturing equipment and systems from implementation and startup through validation.
- Develop and execute CQV lifecycle documentation, including Impact Assessments, URS, FS, HS/SS, FAT, SAT, IQ/OQ/PQ protocols, and summary reports.
- Support aseptic processing simulations (APS), EMPQ, airflow studies, and cleanroom qualification activities.
- Work with CMMS, BMS, EMS, SCADA, MES, LIMS, and EDMS systems.
- Collaborate with Engineering, Quality, Manufacturing, Facilities, and Validation teams to ensure successful project execution.
- Ensure all validation activities comply with GMP requirements and applicable regulatory standards.
- Prepare clear, accurate, and inspection-ready technical documentation.
Required Technical Knowledge
- Working knowledge of 21 CFR Parts 210, 211, and 11.
- Understanding of applicable ISO standards, USP, ISPE GAMP 5, ISPE CQV, EU GMP Annex 1, Annex 11, Annex 15, and ATMP guidelines.
- Experience working in GMP-regulated pharmaceutical, biotechnology, or cell therapy manufacturing environments.
- Knowledge of utility and facility equipment design, implementation, startup, and qualification.
- Experience with cleanroom operations and gowning practices.
- Strong technical writing and documentation skills.
Preferred Experience
- Oral solid dose, biotechnology, pharmaceutical, or cell therapy manufacturing experience.
- Site, facilities, plant, or process engineering experience within a GMP environment.
- Hands-on experience with CMMS, BMS, EMS, SCADA, MES, LIMS, and EDMS platforms.
