CQV Engineer: Lab Expansion (Onsite NC, 12 Mo Contract)

Intellectt INC; North Carolina; On-site; USD 45,000 - 65,000; Part time

Job summary

Intellectt INC is seeking an experienced CQV Engineer to support laboratory expansion and equipment qualification activities within a regulated pharmaceutical/biotech environment in North Carolina. This 12-month contract W2 role is onsite.

The ideal candidate will have hands-on qualification of laboratory equipment, experience executing FAT, SAT, IQ, OQ, and PQ, and knowledge of CSV, URS/FS/DS, 21 CFR Part 11, data integrity, and audit readiness.

Qualifications

• Hands-on qualification of laboratory equipment.
• Experience executing FAT, SAT, IQ, OQ, and PQ.
• Knowledge of Computer System Validation (CSV).
• Experience developing and reviewing URS, FS, and DS.
• Hands-on experience with Kneat tool.

Responsibilities

• Support laboratory expansion and equipment qualification activities in a regulated pharma/biotech environment.
• Develop and execute qualification protocols and associated documentation.
• Collaborate with cross-functional teams to ensure FDA/EMA regulatory expectations are met and maintain audit readiness.

Skills

Lab qualification

FAT/SAT/IQ/OQ/PQ

CSV knowledge

URS/FS/DS development

Kneat

21 CFR Part 11/data integrity

Vendor doc review

Qualification protocols

Tools

Kneat

Job description

Intellectt INC is seeking an experienced CQV Engineer to support laboratory expansion and equipment qualification activities within a regulated pharmaceutical/biotech environment in North Carolina. This 12-month contract W2 role is onsite.

The ideal candidate will have hands-on qualification of laboratory equipment, experience executing FAT, SAT, IQ, OQ, and PQ, and knowledge of CSV, URS/FS/DS, 21 CFR Part 11, data integrity, and audit readiness.