Validation Engineer

Intellectt INC; Harmans (MD); On-site; USD 45,000 - 65,000; Full time

Benefits offered by this job

Health Insurance

Retirement Plan (401k)

Paid Time Off

Job summary

Intellectt Inc. is seeking a Validation Engineer in Harmans, MD to support GMP/GDP regulated pharma/biotech projects. You will map CTU temperatures, qualify equipment, and develop validation documentation in an onsite W2 contract role.

The ideal candidate has 2–5+ years of GMP-regulated experience and hands-on qualification expertise. The position emphasizes adherence to site procedures and timely validation reporting.

Qualifications

• 2–5+ years GMP-regulated pharma/biotech experience.
• Hands-on CTU temperature mapping and equipment qualification experience.
• Experience reviewing deviations, change controls, EMS trends and alarms.

Responsibilities

• Execute temperature mapping for CTUs and equipment across multiple units.
• Develop and execute validation and requalification protocols.
• Prepare and review validation reports and qualification documents.
• Review deviations, change controls, EMS trends, and alarms.
• Ensure GMP/GDP compliance and site procedures.

Skills

CTU Temperature Mapping

Equipment Qualification

Requalification

GMP/GDP

Validation Documentation

Job description

Job Title: Validation Engineer
Company: Intellectt Inc.
Location: Harmans, Maryland
Employment Type: W2 Contract
Pay Rate: $40/hr on W2
Work Arrangement: Onsite

Job Description

Intellectt Inc. is seeking a Validation Engineer with 2 5+ years of GMP-regulated pharma/biotech experience. Must have hands-on experience with Controlled Temperature Unit (CTU) temperature mapping, equipment qualification, requalification, and periodic reviews.

Key Responsibilities

• Execute temperature mapping for freezers, refrigerators, incubators, and LN2 units.
• Develop and execute validation and requalification protocols.
• Prepare and review validation reports and qualification documents.
• Review deviations, change controls, EMS trends, and alarms.
• Ensure compliance with GMP, GDP, and site procedures.

Primary Skills

CTU Temperature Mapping, Equipment Qualification, Requalification, GMP/GDP, Validation Documentation.

Benefits

Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.