Validation Engineer

Validation Engineer II
Location: 14905 Kirby Drive, Houston, TX 77047
Contract Duration: 6 Months — Potential Extension or Full-Time Conversion
Pay Rate: $50.00–$63.85/hour (W2)
Benefits: Weekly Pay, Medical, Dental, and Vision Insurance

Position Overview
We are seeking aValidation Engineer II to support validation and commissioning activities for equipment, utilities, facilities, and controlled temperature units within a regulated pharmaceutical/biopharmaceutical environment. The ideal candidate will have hands-on experience developing and executing validation protocols, analyzing validation data, and ensuring compliance with cGMP and applicable FDA regulations.
 
Key Responsibilities

• Develop and execute validation protocols and reports forequipment, utilities, and facilities, includingIQ, OQ, and PQ.
• Develop and executeCommissioning, Qualification, and Validation (CQV) deliverables fortemperature mapping of Controlled Temperature Units (CTUs).
• Coordinate validation activities with cross-functional teams, includingManufacturing, Quality Assurance, Engineering, and R&D.
• Review and analyze validation data, identify deviations, and recommend appropriateCorrective and Preventive Actions (CAPAs).
• Prepare and present validation summaries, reports, and supporting documentation forinternal and external audits.
• Participate in the review and approval ofchange controls associated with validated systems and equipment.
• Ensure validation activities are conducted in accordance with applicable regulatory requirements, company procedures, and quality standards.

• Bachelor’s degree inEngineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
• 2–6 years of validation experience within the pharmaceutical, biopharmaceutical, or other regulated industry.
• Strong knowledge ofcGMP, ICH guidelines, and FDA regulations, including21 CFR Parts 210, 211, and 820.
• Proven hands-on experience withIQ, OQ, and PQ activities.
• Experience developing, executing, and documenting validation protocols and reports.
• Strong analytical and problem-solving skills, with the ability to evaluate validation data and address deviations.

• Hands-on experience withtemperature mapping of Controlled Temperature Units (CTUs).
• Familiarity withFDA and cGMP requirements related to equipment and facility validation.
• Experience supportingCQV activities in pharmaceutical or biopharmaceutical manufacturing environments.
• Experience working collaboratively with Manufacturing, QA, Engineering, and R&D teams.
• Strong technical writing and documentation skills.

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