Job Title: Instrument Validation Specialist
Domain: Medical Devices
Location: Louisville, KY (100% Remote Occasional onsite to client location)
Job Type: W2 Contract
Duration: 12+ Months
Experience:10+
We are seeking an Instrument Validation Specialist to support validation, integration, and compliance activities for laboratory instrument software and devices within a regulated Life Sciences environment. The role will ensure instrument software and integrations are validated and documented in accordance with EMA regulations, GxP requirements, and internal SOPs.
Key Responsibilities
* Document and validate software installed on laboratory instruments in compliance with EMA regulatory standards and GxP requirements.
* Plan, execute, and document instrument integration validation activities, including interface and data transfer testing.
* Support migration of instrument software management processes to align with PPD IT SOPs and validation standards.
* Capture, document, and maintain software requirements, system configurations, and validation records.
* Develop and execute validation documentation, test cases, protocols, and reports.
* Support change control, audit readiness, and regulatory compliance activities.
Required Qualifications
* Proven experience in instrument or medical device validation within a regulated GxP environment.
* Experience performing instrument integration validation and testing.
* Strong technical writing skills, including development of validation documentation, protocols, and test cases.
* Knowledge of Computer System Validation (CSV), data integrity, and regulatory requirements.
* Ability to work effectively with laboratory, quality, IT, and vendor stakeholders.
Preferred Qualifications
* Experience with laboratory instruments and laboratory informatics systems (LIMS, CDS, ELN).
* Familiarity with EMA Annex 11, GAMP 5, and 21 CFR Part 11 requirements.
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