Senior CQV Validation Engineer

Katalyst-Healthcares-; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst-Healthcares- seeks a Validation Contractor to oversee CQV activities in a regulated pharma/medical device environment. The role ensures facilities, equipment, utilities, and processes meet cGMP and regulatory standards.

Responsibilities include reviewing URS and IQ/OQ/PQ documents, supporting CSV and validation activities, and contributing to audits and KPI reporting. Collaboration across MSAT, Engineering, Manufacturing, and QC is essential.

Qualifications

• 7+ years in pharma/medical device industries required.
• 5+ years hands-on CQV/engineering experience.
• Strong knowledge of 21 CFR Parts 210/211, 600, 820; ISO 13485/9001; ICH Q9/Q10.
• Proven ability to review qualification/validation protocols and reports.
• Experience supporting deviations, CAPAs, change controls and regulatory inspections.

Responsibilities

• Author/review/approve URS, IQ/OQ/PQ protocols and reports.
• Oversee equipment qualification, CSV, cleaning validation and process validation.
• Review APQRs and maintain site Validation Master Plans (VMPs).
• Serve as Quality Validation SME for deviations, CAPAs, change controls.
• Collaborate with MSAT, Validation, Engineering, Manufacturing and QC teams during FAT/SAT and startup activities.
• Support internal and external audits and regulatory inspections.

Skills

7+ years pharma/med device

CQV/engineering experience

Regulatory knowledge (21 CFR ISO etc)

Protocol review & IQ/OQ/PQ

CAPA/change controls

QMS software (Documentum/Veeva/TrackW)

Analytical/problem-solving

Cross-functional collaboration

Education

Bachelor's degree in engineering or related

Tools

Documentum

Veeva Vault

TrackWise

Job description

Katalyst-Healthcares- seeks a Validation Contractor to oversee CQV activities in a regulated pharma/medical device environment. The role ensures facilities, equipment, utilities, and processes meet cGMP and regulatory standards.

Responsibilities include reviewing URS and IQ/OQ/PQ documents, supporting CSV and validation activities, and contributing to audits and KPI reporting. Collaboration across MSAT, Engineering, Manufacturing, and QC is essential.