CQV Validation Specialist

2 days ago

Columbia, South Carolina, United States Novozen Healthcare LLC Full time
CQV Engineer Job Description

We are seeking a highly skilled CQV Engineer to join our team at Novozen Healthcare LLC in ensuring the commissioning, qualification, and validation of pharmaceutical/biotech equipment, utilities, and facilities in compliance with Good Manufacturing Practices (GMP).

Key Responsibilities:

  • Lead and perform commissioning, qualification, and validation activities for manufacturing equipment, clean utilities, HVAC systems, and lab instruments within GMP environments.
  • Develop and execute IQ, OQ, PQ protocols (Installation Qualification, Operational Qualification, Performance Qualification) for new and existing systems.
  • Author, review, and approve CQV documentation, including validation master plans, protocols, and reports.
  • Conduct risk assessments and gap analyses to ensure equipment and facilities meet regulatory compliance (FDA, EMA).
  • Support validation lifecycle management for equipment, facilities, and utilities, ensuring continuous GMP compliance.
  • Collaborate with cross-functional teams (manufacturing, quality, engineering) to ensure efficient project execution.
  • Troubleshoot issues identified during commissioning or validation and ensure corrective and preventive actions (CAPA) are implemented.
  • Participate in deviation investigations, change control, and impact assessments related to equipment and system changes.
  • Ensure all validation activities comply with relevant SOPs, industry regulations, and guidelines (FDA, ISO, ICH).

Qualifications:

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 2-5 years of experience in CQV within the pharmaceutical/biotech industry.
  • Strong understanding of GMP, FDA regulations, and pharmaceutical validation principles.
  • Experience in validating process equipment, clean utilities, HVAC systems, and lab instruments.
  • Familiarity with autoclaves, bioreactors, chromatography systems, or fill-finish equipment is a plus.
  • Ability to author and review validation documents such as protocols, test scripts, and reports.
  • Excellent problem-solving skills and ability to conduct thorough root cause analysis.
  • Ability to work in a fast-paced environment and manage multiple projects concurrently.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.

Preferred Skills:

  • Knowledge of cell & gene therapy processes and equipment validation.
  • Experience with automation systems and process analytical technology (PAT).
  • Six Sigma or Lean Manufacturing certification is a plus.

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