Pharma CQV Validation Engineer II

Creative Solutions Services, LLC; Houston (TX); On-site; USD 85,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Validation Engineer II to support CQV activities in a pharmaceutical manufacturing setting. You will develop and execute IQ, OQ, and PQ protocols for equipment, utilities, facilities, and controlled temperature units, ensuring compliant validation deliverables.

The role requires hands-on CQV experience, strong data analysis, temperature mapping skills, and collaboration with Manufacturing, QA, Engineering, and R&D to drive continuous improvement and

Qualifications

• Bachelor's degree in Chemical, Biomedical, or Mechanical Engineering or a related field.
• 2–6 years of validation engineering experience.
• Experience in pharmaceutical or biopharmaceutical industries.
• Hands-on CQV deliverables development and execution.
• Strong IQ, OQ, and PQ protocol experience.
• Familiarity with cGMP, ICH guidelines, and FDA regulations.
• Experience supporting CAPA and change controls.
• Cross-functional collaboration skills.

Responsibilities

• Develop, review, and execute CQV deliverables for pharmaceutical and biopharmaceutical systems.
• Perform IQ, OQ, and PQ for equipment, utilities, facilities, and controlled temperature units.
• Lead temperature mapping studies for CTUs and controlled environments.
• Ensure validation activities comply with cGMP requirements, ICH guidelines, and FDA regulations.
• Analyze validation data, identify trends, and verify acceptance criteria.
• Investigate validation deviations and support root cause analysis and corrective actions.
• Develop, track, and implement CAPAs.
• Manage change controls for validated systems and assess impact on qualification status.
• Prepare validation protocols, reports, and other CQV documentation.
• Support audits by preparing validation records and presenting validation activities.
• Collaborate with Manufacturing, QA, Engineering, and R&D teams to ensure successful validation execution.
• Maintain accurate and compliant validation documentation.
• Support continuous improvement of validation processes.

Skills

CQV knowledge

IQ/OQ/PQ execution

cGMP compliance

FDA regulations familiarity

Temperature mapping

Data analysis

Cross‑functional collaboration

Education

Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related scientific discipline

Job description

Creative Solutions Services, LLC is seeking a Validation Engineer II to support CQV activities in a pharmaceutical manufacturing setting. You will develop and execute IQ, OQ, and PQ protocols for equipment, utilities, facilities, and controlled temperature units, ensuring compliant validation deliverables.

The role requires hands-on CQV experience, strong data analysis, temperature mapping skills, and collaboration with Manufacturing, QA, Engineering, and R&D to drive continuous improvement and