Pharma Validation Engineer II - CQV & CTU Specialist

Creative Solutions Services, LLC; Houston (TX); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Weekly Pay

Medical Insurance

Dental Insurance

Vision Insurance

Job summary

Creative Solutions Services, LLC is seeking a Validation Engineer II to support validation and commissioning activities for equipment, utilities, facilities, and controlled temperature units in a regulated pharmaceutical environment.

The ideal candidate has hands-on experience with IQ, OQ, PQ, CQV, and temperature mapping of CTUs, ensuring compliance with cGMP and FDA regulations while coordinating cross-functional teams and contributing to audit readiness.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline.
• 2–6 years of validation experience in pharma/biopharma or regulated industry.
• Strong knowledge of cGMP, ICH guidelines, and FDA regulations (21 CFR Parts 210, 211, 820).
• Hands-on experience with IQ, OQ, and PQ activities.
• Experience documenting validation protocols and reports.

Responsibilities

• Develop and execute validation protocols for equipment, utilities, and facilities including IQ, OQ, and PQ.
• Produce CQV deliverables for temperature mapping of CTUs.
• Coordinate validation activities with Manufacturing, QA, Engineering, and R&D.
• Review validation data, identify deviations, and implement CAPAs.
• Prepare validation summaries and documentation for audits.
• Review and approve change controls for validated systems and equipment.
• Ensure activities comply with regulatory requirements and company procedures.

Skills

Regulatory knowledge

Analytical thinking

Technical writing

Cross-functional collaboration

Education

Engineering degree

Tools

IQ/OQ/PQ

CQV

CTU temperature mapping

Job description

Creative Solutions Services, LLC is seeking a Validation Engineer II to support validation and commissioning activities for equipment, utilities, facilities, and controlled temperature units in a regulated pharmaceutical environment.

The ideal candidate has hands-on experience with IQ, OQ, PQ, CQV, and temperature mapping of CTUs, ensuring compliance with cGMP and FDA regulations while coordinating cross-functional teams and contributing to audit readiness.