Job Title: Validation Engineer
Location: Harmans, Maryland
Pay Rate: $45/hour
Position Overview
We are seeking an experienced Validation Engineer to support equipment qualification, temperature mapping, requalification, and periodic review activities at a pharmaceutical or biotechnology facility. The ideal candidate will have hands-on experience with Controlled Temperature Units (CTUs) and strong technical documentation skills within a GMP-regulated environment.
Key Responsibilities
- Author, route for approval, and close periodic review reports for qualified equipment and systems.
- Review deviations, Quality Corrective Actions (QCAs), change controls, BMRAM work orders, Environmental Monitoring System (EMS) trends, and previous validation documentation.
- Author and execute requalification protocols for CTUs, including 20 C and 80 C freezers, liquid nitrogen (LN2) units, refrigerators, and incubators.
- Perform loaded-chamber temperature mapping studies to verify temperature uniformity and equipment performance.
- Conduct EMS and alarm verification activities against established requirements.
- Prepare, review, and finalize temperature mapping and requalification reports.
- Ensure validation activities and documentation comply with GMP, Good Documentation Practices (GDP), and site procedures.
- Complete project deliverables within established timelines.
Required Qualifications
- 2 5+ years of validation experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Hands-on experience performing temperature mapping of CTUs.
- Knowledge of equipment qualification, periodic reviews, and requalification protocols.
- Strong understanding of GMP and GDP requirements.
- Excellent technical writing, documentation, and report preparation skills.
- Ability to work independently and manage assigned deliverables.
- Preferred Qualifications
- Experience with cryogenic or liquid nitrogen storage units.
- Experience with EMS monitoring systems, temperature alarms, and trend reviews.
- Familiarity with deviations, change controls, and quality documentation systems.
- Experience executing loaded-chamber temperature mapping studies.
Recruiter Contact
Pavani Samboju
Email:
pavani.samboju@intellectt.com
.
Phone:732 784 4384Benefits:
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.