Manufacturing Equipment Qualification Engineer IQ/OQ/PQ

Capgemini Engineering; McLean (VA); On-site; USD 69,000 - 162,000; Full time

Benefits offered by this job

Paid time off

Healthcare coverage

Retirement plans

Life and disability insurance

Employee assistance programs

Job summary

Capgemini Engineering seeks a qualified professional to oversee IQ/OQ/PQ qualification activities for equipment and systems in regulated environments. You will verify installations, document processes, develop and approve protocols, run tests, and train staff to ensure compliance and traceability.

With 3+ years of experience in CSV and validation, you will drive documentation, corrective actions, and training across cross‑functional teams in a dynamic setting.

Qualifications

• Bachelor's degree in Science, Engineering, or related field.
• Experience executing IQ/OQ/PQ protocols
• Experience developing Validation Master Plans (VMPs) and validation reports
• Experience managing Change Controls, Deviations, CAPAs, and inspection readiness
• Strong communication and cross‑functional collaboration skills

Responsibilities

• Verify equipment installation according to manufacturer specifications and site requirements.
• Document the installation process, including utility connections, environmental conditions, and component verification.
• Ensure documentation such as manuals and certificates is available and complete.
• Develop and approve OQ protocols outlining tests for verifying equipment operation.
• Conduct tests to verify equipment operation under normal conditions.
• Document test results, deviations, and corrective actions.
• Develop and approve PQ protocols for tests under production conditions.
• Conduct tests to ensure equipment performs consistently to specifications.
• Develop and conduct training programs for staff on IQ/OQ/PQ procedures and protocols.

Skills

IQ/OQ/PQ execution

CSV

Validation Master Plans

Validation protocols

Change Controls

Deviations

CAPAs

Inspection readiness

Cross-functional collaboration

Communication

Regulatory compliance

Education

Bachelor's degree in Science, Engineering, or related field

Job description

Capgemini Engineering seeks a qualified professional to oversee IQ/OQ/PQ qualification activities for equipment and systems in regulated environments. You will verify installations, document processes, develop and approve protocols, run tests, and train staff to ensure compliance and traceability.

With 3+ years of experience in CSV and validation, you will drive documentation, corrective actions, and training across cross‑functional teams in a dynamic setting.