Validation Engineer - Regulatory IQ/OQ/PQ & Audit Readiness

Ushitecsolutions; Raleigh (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

A pharmaceutical solutions provider in Raleigh, North Carolina is seeking a Validation Engineer to ensure compliance with FDA and ICH guidelines. The ideal candidate will have a degree in Engineering or Life Sciences and 2–5 years of validation experience. Responsibilities include executing validation protocols and maintaining regulatory compliance. Excellent problem-solving skills and experience in a fast-paced environment are required. This position offers opportunities for continuous improvement in validation processes.

Qualifications

• 2–5 years of hands-on experience in validation within the pharmaceutical or biotech industry.
• Strong understanding of FDA compliance standards.
• Experience with equipment, facility, cleaning, or software validation preferred.

Responsibilities

• Plan and execute validation activities in compliance with regulatory guidelines.
• Develop and execute IQ, OQ, and PQ protocols.
• Ensure validation documentation aligns with regulatory guidelines.

Skills

Understanding of cGMP

Validation protocols writing

Problem-solving

Multitasking abilities

Collaboration with cross-functional teams

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

A pharmaceutical solutions provider in Raleigh, North Carolina is seeking a Validation Engineer to ensure compliance with FDA and ICH guidelines. The ideal candidate will have a degree in Engineering or Life Sciences and 2–5 years of validation experience. Responsibilities include executing validation protocols and maintaining regulatory compliance. Excellent problem-solving skills and experience in a fast-paced environment are required. This position offers opportunities for continuous improvement in validation processes.