CQV Engineer

1 week ago

New York, United States Novozen Healthcare LLC Full time

Job Title: CQV Engineer – Pharmaceutical Manufacturing

Strictly no C2C

Job Summary:

We are seeking an experienced CQV Engineer to join our dynamic team in a pharmaceutical manufacturing environment. The ideal candidate will have a minimum of 4 years of hands-on experience in Commissioning, Qualification, and Validation (CQV) activities. This role requires a deep understanding of GMP (Good Manufacturing Practice) environments, with a focus on equipment, process validation, and utilities in the pharma and biopharma sectors.

Key Responsibilities:

  • Lead the planning and execution of commissioning, qualification, and validation activities for equipment, processes, and utilities.
  • Develop and execute IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) protocols for new and modified systems.
  • Ensure compliance with regulatory standards (FDA, EMA, etc.) and internal quality policies during all CQV activities.
  • Perform risk assessments, gap analyses, and provide mitigation strategies to ensure successful validation outcomes.
  • Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Conduct root cause analysis for validation discrepancies and deviations; support troubleshooting and problem resolution.
  • Collaborate with cross-functional teams (QA, Engineering, Manufacturing) to ensure timely and successful project execution.
  • Support the development and maintenance of the Validation Master Plan (VMP).
  • Participate in site audits and inspections related to CQV processes.

Qualifications:

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • 4+ years of experience in CQV activities within the pharmaceutical or biopharmaceutical industry.
  • Strong knowledge of regulatory requirements, including FDA, EMA, ICH Q7, and GAMP guidelines.
  • Hands-on experience with validation of pharmaceutical equipment (e.g., autoclaves, bioreactors, lyophilizers) and processes (e.g., aseptic processes, sterilization, cleaning validation).
  • Familiarity with GMP, GEP (Good Engineering Practices), and regulatory inspection processes.
  • Excellent problem-solving skills and ability to work in a fast-paced environment.
  • Strong communication and organizational skills.

Preferred Skills:

  • Experience with computerized system validation (CSV).
  • Experience in cell and gene therapy or biologics manufacturing environments.
  • Familiarity with lean manufacturing principles and continuous improvement methodologies.

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