QC Systems Specialist Lab Equipment CSV

Advanced Manufacturing Tech Solutions (AMTSOL)
www.amtsol.com

A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

Job Description

QC Systems Specialist – Lab Equipment CSV
Target Hire: March
Industry: Biotech / Pharmaceutical Manufacturing
Experience – 5-10 yrs

Role Summary
We are seeking an experienced QC Systems Specialist with strong expertise in laboratory equipment computer system validation (CSV) and hands-on exposure as a laboratory equipment SME within GMP-regulated environments. The role will support the full lifecycle of QC laboratory systems and equipment, providing validation oversight, qualification guidance, change control support, and data integrity assurance while working closely with Quality, Validation, Engineering, and Operations teams.

Key Responsibilities

• Support QC laboratory systems and equipment lifecycle activities, acting as a key SME for validation and compliance
• Review and approve validation lifecycle documentation, including URS, risk assessments, IQ/OQ/PQ, and qualification reports
• Support commissioning, qualification, salvaging, and decommissioning documentation reviews, including deviation and exception closures
• Provide technical and compliance guidance on commissioning/qualification and decommissioning strategies
• Support and assess change controls, including impact assessments and documentation reviews
• Perform and support data integrity assessments, gap analysis, and remediation actions
• Provide SME input for laboratory instruments and computerized systems, including analytical instruments and controlled temperature units
• Ensure alignment with GMP, GDP, and data integrity (ALCOA+) requirements
• Collaborate cross-functionally to deliver activities safely, on time, and in compliance

Specialisation / Scope Focus

• Laboratory Equipment CSV (QC systems)
• Analytical instruments and computerized lab systems
• Controlled Temperature Units (CTU) / environmental chambers qualification
• Commissioning, Qualification, and Decommissioning lifecycle support
• Change Control and Data Integrity assessments
• Electronic validation systems (Kneat preferred)

Requirements & Qualifications

• Relevant experience in biotech or pharmaceutical operations
• Strong understanding of CSV methodologies, validation strategies, and lifecycle management
• Hands-on experience as a lab equipment SME within QC environments
• Working knowledge of Kneat or similar electronic validation tools
• Experience supporting change control processes in regulated environments
• Solid knowledge of Data Integrity, GMP, and GDP requirements
• Ability to work independently with minimal supervision
• Team player with strong focus on safety, quality, and timelines