Validation Engineer

Katalyst CRO; Houston (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Katalyst CRO is seeking a Validation Engineer II with extensive experience in the pharmaceutical/biopharmaceutical sector. You will contribute to IQ/OQ/PQ validation programs and CTU temperature mapping, collaborating with QA, Manufacturing, Engineering, and R&D to ensure compliant validated systems.

Experience with regulatory requirements (cGMP, FDA 21 CFR Parts 210, 211, 820, ICH guidelines) and strong data analysis skills are essential for success in this role.

Qualifications

• Bachelor's degree in Engineering and 26 years of validation experience in pharmaceutical/biopharmaceutical industry.
• Strong knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211 & 820) and ICH guidelines.
• Hands-on IQ/OQ/PQ and Temperature Mapping of CTUs required.

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/Temperature Mapping

Cross-functional collaboration

Deviation analysis & CAPA

Regulatory knowledge (cGMP, FDA, ICH)

Validation reporting & audits

Change controls

Temperature mapping for CTUs

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.

• 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.

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).
• 26 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.