Validation Engineer

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

As a Validation Engineer, you will be responsible for planning, executing, and maintaining validation activities for equipment, systems, and utilities in compliance with FDA, EU, and ICH guidelines.

You will collaborate with cross‑functional teams to ensure all systems meet regulatory requirements and support continuous improvement of validation processes.

Validation Planning and Execution

Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment and systems.

Lead validation efforts for manufacturing, cleaning, and laboratory equipment to ensure compliance with internal and external standards.

Author and update Validation Master Plans (VMPs), SOPs, and technical reports.

Conduct risk assessments and deviation investigations related to validation activities.

Ensure validation documentation aligns with FDA, EU, and ICH regulatory guidelines.

Compliance and Cross‑Functional Support

Provide validation support during audits and inspections, ensuring readiness and compliance.

Collaborate closely with Quality Assurance (QA), Engineering, Manufacturing, and R&D teams to achieve validation objectives.

Support continuous improvement by identifying opportunities to optimize validation procedures and documentation practices.

Maintain compliance with CDISC, ICH GCP, and 21 CFR Part 11 throughout all data processes.

Lead and contribute to the development of departmental SOPs, data standards, and process improvements.

Compliance and Quality Oversight

Ensure data management activities meet global regulatory and quality standards (FDA, EMA, PMDA).

Support inspection readiness and risk‑based quality management (RBQM).

Partner with cross‑functional teams to implement data governance frameworks and uphold data integrity.

Apply best practices in clinical data compliance, CDASH, and validation standards such as Pinnacle21.

Required Skills

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• 2–5 years of hands‑on experience in validation within the pharmaceutical or biotech industry.
• Strong understanding of cGMP, FDA, 21 CFR Part 11, ICH Q7/Q8, and Annex 15 compliance standards.
• Skilled in writing clear and compliant protocols and validation reports.
• Excellent problem‑solving and multitasking abilities in a fast‑paced environment.
• Experience with equipment, facility, cleaning, or software validation preferred.