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 Title: Computer System Validation (CSV) Engineer / Specialist

Role Overview

We are looking for a Mid-Level CSV Engineer to support validation activities for GMP-regulated computerized systems across manufacturing, packaging, and laboratory environments. The role focuses on hands-on execution of CSV lifecycle deliverables, working closely with Quality, Engineering, IT, and project teams to ensure compliance and timely delivery.

Key Responsibilities

• Execute CSV lifecycle activities for GMP computerized systems, including MES, DCS, SCADA, and automated equipment
• Prepare, review, and support approval of CSV documentation (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ, Reports)
• Support risk-based validation approaches for new and existing systems
• Ensure CSV activities comply with cGMP, GAMP 5, Annex 11, and 21 CFR Part 11
• Support project teams to align validation activities with project timelines
• Participate in validation risk assessments to define appropriate testing scope
• Review system specifications, design documents, installation records, and qualification documentation
• Support CSV activities across manufacturing, packaging, and laboratory systems
• Generate, track, and support closure of validation deviations and discrepancies
• Support investigations and assess data integrity risks during validation and routine operations
• Perform periodic reviews of computerized systems and assist in identifying compliance gaps
• Support the development and maintenance of CSV / Qualification SOPs
• Assist in regulatory inspections and internal audits
• Collaborate with local and global CSV teams to ensure consistent execution
• Escalate potential quality or compliance issues to senior CSV or Quality leads
• Follow EHS and site safety procedures during commissioning and validation activities

Qualifications & Experience

• Bachelors degree in Engineering, Life Sciences, Computer Science, or related discipline
• 4–7 years of experience in Computer System Validation within a regulated pharma / biopharma environment
• Solid understanding of CSV regulations and quality expectations
• Hands-on experience validating GAMP Category 3, 4, and 5 systems
• Experience executing validation protocols and managing validation documentation
• Working knowledge of Annex 11, 21 CFR Part 11, and GAMP guidelines
• Experience supporting investigations, root cause analysis, and CAPAs
• Strong documentation, and cross-functional collaboration skills