CQV Engineer

We are actively seeking an experienced Sr. CQV Specialist to support Commissioning, Qualification, and Validation (CQV) activities within a cGMP-regulated clinical and commercial cell therapy manufacturing environment
. This is an excellent opportunity to work on cutting‑edge, high‑impact projects in a fast‑paced and highly regulated setting.

• Execute commissioning, qualification, and validation activities for facilities, utilities, equipment, and systems
• Author, review, and execute CQV protocols, validation plans, and summary reports
• Manage multiple CQV projects and coordinate with cross‑functional teams, vendors, and contractors
• Support deviations, CAPAs, change controls, and risk assessments (FMEA)
• Ensure compliance with cGMP, GDP, FDA, and global regulatory standards
• Support audits and regulatory inspections with validation documentation
• Contribute to SOP updates, validation lifecycle management, and data integrity initiatives
• Mentor junior team members and support continuous improvement efforts

• Bachelor’s degree in Engineering, Science, or related field
• 8+ years of CQV/Validation experience in pharma, biotech, medical device, or cell therapy
• Strong experience in aseptic and cGMP-regulated environments
• Experience in cell therapy, biologics, or sterile manufacturing preferred

• CQV lifecycle (Commissioning through Validation)
• Change control, deviations, CAPA, and risk management
• Data integrity and GDP practices

• 21 CFR Parts 210, 211, and 1271
• cGTP and ICH guidelines

• Strong communication and stakeholder management
• Ability to manage multiple priorities independently
• Experience supporting audits and inspections
• Problem‑solving mindset in cross‑functional environments