Advanced Manufacturing Tech Solutions (AMTSOL) -
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