Component Engineer Validation (IQ/OQ/PQ)

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description:

Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards.

Roles & Responsibilities:

• Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.
• Collaborate with cross-functional teams (QA, R&D, Manufacturing) to evaluate and qualify new components.
• Conduct risk assessments (FMEA) and support design and process changes.
• Coordinate with suppliers for part approval, PPAPs, and validation documentation.
• Ensure all validations meet regulatory compliance (21 CFR Part 820, EU MDR, ISO 14971.)
• Support CAPA and non-conformance investigations related to component failures.
• Validation protocols (IQ, OQ, PQ.).
• Component qualification and material review.
• Regulatory knowledge (FDA, ISO 13485, cGMP.)
• Root cause analysis, CAPA.
• Supplier qualification and audits.

All your information will be kept confidential according to EEO guidelines.