CQV Validation Engineer

Responsibilities

• Develop and execute validation protocols and reports for equipment, utilities, and facilities (IQ, OQ, PQ).
• Develop and execute CQV deliverables for Temperature Mapping (Controlled Temperature Units).
• Cook up validation activities with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and R&D.
• Analyze validation data, identify deviations, and recommend corrective and preventive actions (CAPAs).
• Prepare and present validation summaries and reports to internal and external auditors.
• Participate in the review and approval of change controls related to validated systems.

Requirements

• Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
• 2-6 years of validation experience in the biopharmaceutical or pharmaceutical industry.
• Strong knowledge of cGMP, ICH guidelines, and FDA regulations (21 CFR Parts 210, 211, and 820).
• Hands-on experience with Temperature Mapping for Controlled Temperature Units.
• Proven experience in IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
• Familiarity with FDA and cGMP standards.
• Experience analyzing validation data, managing deviations, and supporting CAPAs.
• Ability to work collaboratively with cross-functional teams.

Skills

• Strong analytical skills.
• Excellent communication and collaboration abilities.
• Proficient in Microsoft Office Suite.

Benefits

• Flexible working hours.
• Professional development opportunities.
• Competitive compensation package.
• Health insurance benefits.
• Employee assistance program.

Pay

• $35.00 - $45.00 per hour.

Schedule

• Onsite at client location in Houston, TX.