CQV Engineer

Title: Validation Engineer / CQV Engineer – Junior to Mid-Level

Duration: 12 Months (W2 Contract)

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.

• Junior Validation Engineer: 1–3 years of U.S. validation experience
• Mid-Level Validation Engineer: 4–6 years of U.S. validation experience

• 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.

• 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.

• 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.