VALIDATION SUPPORT ENGINEER

Job Description

Job DescriptionCompany Description

• 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

Job Description:

• We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.
• The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.

Responsibilities:

• Develop/update Validation Plans (VP) and Master Validation Plans (MVP).
• Lead GxP risk assessments for system changes.
• Author and execute IQ/OQ/PQ protocols.
• Maintain Requirements Traceability Matrices (RTM).
• Investigate and manage deviations; support RCA and CAPA processes.
• Create Validation Summary Reports (VSR).
• Ensure full compliance with regulatory and quality standards.

Requirements:

• 5–8 years of experience in Computer System Validation (CSV).
• Strong knowledge of FDA regulations and GAMP5.
• Hands-on experience validating PLC-controlled systems.
• Beckhoff Twin CAT PLC and Ether CAT hardware experience is a strong plus.

Additional Information

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