Computer System Validation (CSV) Engineer at Clappr LLC Computer System Validation (CSV) Engineer at Clappr LLC in Stone Park, Illinois Posted in about 17 hours ago.

Type:

full-time We're looking for an experienced CSV Engineer to support validation activities across a wide portfolio of regulated systems

• from laboratory instrumentation to manufacturing equipment to enterprise platforms.

This role acts as the connective tissue between Quality, IT, Lab, and Manufacturing, keeping systems validated and maintained in compliance with 21 CFR Part 11, GxP, and EMA requirements. This is an onsite role reporting to the Sr. Director of IT, and candidates must be authorized to work in the U.S. without current or future sponsorship. Contract to

Hire:

$60

• 65/hour What you'll do Plan, author, and execute validation deliverables
• including Validation Plans, URS, FS, DS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports
• across assigned systems Support CSV activities spanning lab instruments (HPLC, GC, spectrophotometers, balances, and similar), engineering and manufacturing equipment, and enterprise systems such as Caliber LIMS, SAP, and BMRAM Partner with system owners, QA, and IT to keep systems in a validated state through change control and periodic review Execute risk assessments and data integrity assessments aligned with ALCOA+ principles Support audits, inspections, CAPA investigations, and deviations involving computerized systems Collaborate with senior validation leads and subject matter experts to drive consistent validation practices across sites What you'll bring Bachelor's degree in Life Sciences, Engineering, or IT•or equivalent laboratory experience in a life sciences environment Minimum 5 years of CSV experience in a GxP-regulated environment Working knowledge of 21 CFR Part 11, EU Annex 11, and EMA guidance Hands-on experience authoring and executing

IQ/OQ/PQ

protocols Validation experience with at least two of: laboratory instruments, engineering/manufacturing equipment, LIMS, SAP, or CMMS/calibration platforms (e.g., BMRAM) Nice to have Familiarity with GAMP 5 principles and risk-based validation approaches Exposure to Caliber LIMS Exposure to SAP (QM, MM, PP) in a GxP context Experience with BMRAM or an equivalent CMMS/calibration system Prior experience serving as a liaison across IT, Quality, Lab, and Manufacturing teams Benefits & perks This is an onsite position in a fast-paced, deadline-driven setting. It may require extended hours or occasional weekend work, and moderate domestic travel. Physical requirements are light