Validation Engineer

Creative Solutions Services, LLC; Houston (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Creative Solutions Services, LLC in Houston, TX seeks a Validation Engineer II to develop and execute IQ/OQ/PQ validation protocols for equipment, utilities and facilities, including temperature mapping of CTUs.

In this role you will collaborate with Manufacturing, QA, Engineering, and R&D, analyze data, investigate deviations, and support CAPA, audits, and change controls to ensure cGMP compliance.

Qualifications

• Experience executing IQ/OQ/PQ validation protocols and reports.
• Analyze validation data and support CAPA implementation.
• Prepare validation reports and support internal/external audits.

Responsibilities

• Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
• Perform CQV activities, including Temperature Mapping for CTUs.
• Collaborate with Manufacturing, QA, Engineering, and R&D teams.
• Analyze validation data, investigate deviations, and support CAPA implementation.
• Prepare validation reports and support internal/external audits.
• Review and support change controls for validated systems.

Skills

IQ/OQ/PQ validation

CQV activities

Temperature mapping

Deviation analysis

Audit support

Education

Bachelor's degree in Engineering

Chemical/Biomedical/Mechanical or related

Job description

Summary

We are looking for a Validation Engineer II with experience in the pharmaceutical or biopharmaceutical industry to join our growing team.

Roles & Responsibilities

• Develop and execute IQ, OQ, PQ validation protocols and reports for equipment, utilities, and facilities.
• Perform CQV activities, including Temperature Mapping for Controlled Temperature Units (CTUs).
• Collaborate with Manufacturing, QA, Engineering, and R&D teams.
• Analyze validation data, investigate deviations, and support CAPA implementation.
• Prepare validation reports and support internal/external audits.
• Review and support change controls for validated systems.

Education & Experience

• Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline).
• 2–6 years of validation experience in the pharmaceutical or biopharmaceutical industry.
• Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820), and ICH guidelines.
• Hands‑on experience with IQ/OQ/PQ and Temperature Mapping of Controlled Temperature Units is required.