Senior CQV Validation Engineer | Quality & Compliance SME

Tekhawks LLC.; Greenville (NC); On-site; USD 96,000 - 165,000; Full time

Job summary

Tekhawks LLC. seeks a Validation Contractor to oversee CQV programs within a regulated pharmaceutical/medical device environment. You will ensure facilities, equipment, utilities, cleaning procedures, and manufacturing processes stay compliant with cGMP and regulatory standards.

Your role includes authoring and approving URS, IQ/OQ/PQ protocols, reviewing APQRs, maintaining VMPs, and supporting audits. Collaboration across MSAT, Validation, Engineering, and QC is essential to success.

Qualifications

• Minimum of 7 years of experience in the pharmaceutical or medical device industry.
• Minimum of 5 years hands-on Engineering, Validation, or CQV experience.
• Strong working knowledge of 21 CFR Parts 210/211, 600, and 820; ISO 13485/9001; ICH Q9/Q10.
• Experience reviewing qualification/validation protocols, reports, and supporting documentation.
• Experience supporting deviations, CAPAs, change controls, and regulatory inspection readiness.
• Proficiency with electronic quality management systems (e.g., Documentum, Veeva Vault, TrackWise).
• Excellent communication, organizational, and interpersonal skills.

Responsibilities

• Author, review, and approve URS, IQ/OQ/PQ protocols and reports.
• Provide QA validation oversight for CSV, cleaning validation, and process validation activities.
• Review APQRs and maintain site VMPs.
• Serve as Validation SME for deviations, CAPAs, and change controls.
• Collaborate with MSAT, Validation, Engineering, Manufacturing, and QC teams during FAT/SAT and start-up.
• Support audits and regulatory inspections as Validation SME.
• Monitor and report KPIs and validation package performance.
• Review SOPs and records for cGMP compliance.

Skills

CQV experience

cGMP knowledge

Regulatory readiness

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Documentum

Veeva Vault

TrackWise

Job description

Tekhawks LLC. seeks a Validation Contractor to oversee CQV programs within a regulated pharmaceutical/medical device environment. You will ensure facilities, equipment, utilities, cleaning procedures, and manufacturing processes stay compliant with cGMP and regulatory standards.

Your role includes authoring and approving URS, IQ/OQ/PQ protocols, reviewing APQRs, maintaining VMPs, and supporting audits. Collaboration across MSAT, Validation, Engineering, and QC is essential to success.