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.
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 c GMP, 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 discipline4–7 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
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