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

Computer System Validation (CSV) Engineer / Specialist

Job Description