CQV Engineer-Lab Expansion

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

Hiring: CQV Engineer Lab Expansion

Job Title: CQV Engineer Lab Expansion
Location: North Carolina Onsite
Duration: 12 Months
Employment Type: Contract W2
Pay Rate: $40/hr(DOE) on W2

We are seeking an experienced CQV Engineer to support laboratory expansion and equipment qualification activities within a regulated pharmaceutical/biotech environment.

Job Requirements:

• Strong hands-on experience with laboratory equipment qualification

• Experience executing FAT, SAT, IQ, OQ, and PQ

• Knowledge of Computer System Validation (CSV)

• Experience developing/reviewing URS, FS, and DS

• Hands-on experience with Kneat

• Strong understanding of 21 CFR Part 11, GxP, data integrity, and audit readiness

• Experience performing risk assessments and reviewing vendor documentation

• Ability to develop and execute qualification protocols and associated documentation

• Understanding of FDA/EMA regulatory expectations

• Strong documentation and cross-functional communication skills

• Ability to support onsite activities and occasional weekend execution

• Candidates must be able to provide 2 managerial references