Validation Engineer

Katalyst CRO; Framingham (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a Validation Engineer to ensure compliance with regulatory standards. This role involves executing validation activities for non-product software, preparing trace matrices, and conducting risk assessments to develop effective testing strategies. The ideal candidate will possess extensive experience in the manufacturing sector, particularly within medical devices or diagnostics. Join a forward-thinking company where your expertise will contribute to maintaining high-quality standards and regulatory compliance in a dynamic environment.

Qualifications

• 6-8 Jahre Erfahrung in der Validierung von Software im Fertigungssektor.
• Kenntnisse in der Vorbereitung und Überprüfung von funktionalen Anforderungen.

Responsibilities

• Durchführung von Validierungsaktivitäten in computergestützten Systemen.
• Vorbereitung von Trace-Matrizen zur Sicherstellung der Anforderungen.

Skills

Validation Engineering

GAMP Knowledge

Risk Assessment

SOP Preparation

Tools

FDA Standards

ISO Standards

Job description

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Responsibilities

• Execute validation activities in computerized systems and ensure 21 CFR Part 11 compliance. Knowledge of GAMP is required.
• Prepare trace matrices to ensure requirements are tested to meet the software's intended use.
• Conduct risk assessments for functional requirements and develop testing strategies, implementing technical and procedural controls as mitigation measures.
• Prepare SOPs and work instructions for equipment and software-based systems.

Requirements

• 6 to 8 years of experience as a Non-Product Software Validation Engineer within the manufacturing sector (Medical devices or Diagnostics).
• Experience in validating non-product software for manufacturing equipment according to regulatory standards (FDA, ISO).
• Ability to prepare and review functional requirements, design, and testing documents.
• Experience reviewing SLC deliverables such as validation plans, change requests, user requirements, functional requirements, risk assessments, IQ/OQ/PQ, traceability matrices, release notes, and certification summaries.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Contract
• Industry: Pharmaceutical Manufacturing