Computer System Validation Engineer

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Providence, Rhode Island

Post: Wed, 31 May 2023 06:40:22 GMT

Expires: Wed, 28 Jun 2023 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

CSV with GAMP 5 experience

Equipment-based CSV

IQ and OQ Test Scripts

IQ/OQ/PQ Protocols, as necessary

Create a validation plan using a risk-based approach.

Participate with investigations into qualification failures and assists with remediation plans including deviations and CAPAs associated with qualified/validated systems and equipment.

Contributes to reviews and/or revision of written procedures (SOP).

Assist or lead in equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to the business area.

Create a validation report that verifies compliance to the plan.

Looking for a good match that will fit in with the team.

Have a good attitude and will to take direction.