Acara Solutions, An Aleron Company · 3 days ago

Validation Engineer

Ramsey, NJ

Full-time

Onsite

Mid, Senior Level

$100K/yr - $120K/yr

5+ years exp

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Responsibilities

Primary responsibility is preparation of validation protocols (IQ/OQ) and commissioning documents for equipment and control systems.

Work with control system programmers to develop and execute factory acceptance software test documents.

Work as an integral member of a project team.

Interface with equipment manufacturing companies and internal departments to obtain necessary documents for protocol development.

Field execution/testing of approved validation protocols (IQ/OQ) and commissioning documents.

Coordinate efforts of personnel involved during on-site qualification.

Specify, obtain, and maintain hardware and software for validation testing.

Prepare documents of field visits in a timely and professional manner.

Keep current with latest cGMP's, Validation technology and procedures, ISPE guidelines, and related FDA publications.

Develop, maintain, and enhance positive interpersonal relationships with staff members worldwide.

Qualification

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Validation protocols developmentElectric controls interpretationPneumatic controls interpretationPLC code interpretationTest documentationTest results documentationDeviation recordingDeviation resolutionTroubleshootingControl system programmingCommissioningCalibrationI/O forcingPID loop tuningEquipment serviceEntering restrictive spacesAttention to detail communication writingProblem-solvingComfortable presentingScienceRelated Experience

Required

Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential.

Experience is required in reading and interpreting electric and pneumatic controls, technical design documents, and PLC code.

Travel 25 to 35% to customer sites to perform validation testing of equipment and control systems.

Familiarity with industry accepted practices for documenting test results, recording of deviations, and deviation resolutions.

Must have excellent communication skills and be comfortable presenting the validation results to our customer's project team (QA, validation, project management, etc.).

Must have good troubleshooting skills. Prior experience in control system programming, commissioning, calibration, I/O forcing, PID loop tuning, and/or equipment service is desirable.

Must be willing and be capable to climb ladders and to enter restrictive spaces.