CSV Engineer: Validation & Compliance (Life Sciences)

PSC Biotech® Corporation

Chicago (IL)

In loco

USD 90.000 - 150.000

Tempo pieno

45 ore fa

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Descrizione del lavoro

PSC Biotech® Corporation in the United States is seeking Computer System Validation (CSV) Engineers of varying experience levels to support validation and compliance activities for computerized systems used within regulated life sciences environments. This role covers a wide range of platforms including laboratory, manufacturing, automation, quality, and enterprise applications.

You will author and review validation plans, URS, FS, risk assessments, traceability matrices, test scripts, summary

Competenze

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Biotechnology, Chemistry, or a related discipline.
Experience supporting computerized system validation activities within regulated pharmaceutical, biotechnology, medical device, or related industries.
Understanding of GxP regulations, data integrity requirements, and computerized system compliance principles.
Experience authoring CSV lifecycle documentation and executing validation testing.
Familiarity with risk-based validation methodologies and Computer Software Assurance (CSA) concepts.
Knowledge of electronic records and electronic signature requirements.
Strong technical writing and documentation skills.
Excellent analytical, troubleshooting, and problem-solving capabilities.
Strong communication and stakeholder management skills.
Ability to travel to client sites as required.
Must be authorized to work in the U.S.
No C2C at this time.

Mansioni

Develop and execute CSV documentation in line with regulatory requirements and procedures.
Author and review validation plans, URS, FS, risk assessments, traces, test scripts, reports, and SOPs.
Support implementation and validation of computerized systems through the lifecycle.
Execute IQ/OQ/PQ/UAT and document testing activities.
Conduct risk assessments using risk-based validation and CSA concepts.
Evaluate systems for data integrity and e-record requirements.
Support change control, deviations, CAPA, and periodic reviews.
Collaborate with QA, IT, Automation, Engineering, Manufacturing, and Lab Ops.
Participate in system implementations, upgrades, migrations, and enhancements.
Maintain validated-state through lifecycle activities.
Support regulatory inspections, audits, and client reviews.
Travel to client sites as required.