Computerized System Validation (CSV) Engineer – Decommissioning

Manati - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Summary

Were seeking an experienced CSV Engineer with a strong background in laboratory system validation and instrument decommissioning within a regulated pharmaceutical environment. This role will lead and execute validation data integrity and retirement activities for computerized laboratory systems and related instrumentation ensuring compliance with cGMP FDA 21 CFR Part 11 and Data Integrity requirements.

Key Responsibilities

Plan author execute and close CSV deliverables (e.g. Validation Plans URS Risk Assessments IQ/OQ/PQ Traceability Matrices Validation Summary Reports) for laboratory computerized systems and data collection platforms (databases/LIMS/PC-based instruments).
Lead and perform laboratory instrument decommissioning activities including inventory data/archive strategy chain-of-custody data migration/backup sanitization documented retirement and remediation of data integrity gaps.
Interface with QC Lab Manufacturing Engineering IT/OT and Quality to ensure timely compliant validation and decommissioning outcomes.
Assess systems for 21 CFR Part 11 compliance (audit trails security/ALCOA electronic records/signatures) and implement corrective actions.
Support change control deviations/CAPA and periodic reviews; maintain validation status through the system lifecycle.
Collaborate on PLCs industrial computers and laboratory instrumentation integrations; troubleshoot issues impacting data integrity and validated state.
Generate high-quality technical documentation in English; present results and readiness for internal/external audits.
Contribute to continuous improvement of CSV/decommissioning procedures templates and governance.

Minimum Requirements (Must-Haves)

BS or higher in Chemistry Biology Microbiology Computer Science Information Systems Engineering or related discipline.
>5 years validating laboratory computerized systems in a manufacturing environment with training in validation methodologies technologies and process control computer systems.
Demonstrated knowledge of computerized systems with data collection software (e.g. databases instrument software LIMS/ELN).
Strong working knowledge of cGMP FDA 21 CFR Part 11 and Data Integrity regulations.
Proven experience in Laboratory Instrument Decommissioning execution.
3 years working with PLCs industrial computers or laboratory instrumentation systems.
Background in pharmaceutical products manufacturing.
Excellent technical writing skills (validation/commissioning documentation) and proficiency with MS Office.
Bilingual (English/Spanish).

Preferred Qualifications

Experience with data migration/archiving tools and validated backup/restore processes.
Familiarity with QC lab systems (e.g. chromatography data systems spectroscopy particle counters balances incubators) and their integration/retirement.
Knowledge of GAMP 5 data integrity risk assessments and CSV in hybrid IT/OT architectures.
Audit support experience (FDA EMA corporate QA).

Work Conditions

Onsite role in Manatí PR with cross-functional lab/manufacturing floor interaction.
May require off-shift or weekend work during cutovers shutdowns or critical decommissioning windows.

SummaryWere seeking an experienced CSV Engineer with a strong background in laboratory system validation and instrument decommissioning within a regulated pharmaceutical environment. This role will lead and execute validation data integrity and retirement activities for computerized laboratory syste...

Summary

Key Responsibilities

Plan author execute and close CSV deliverables (e.g. Validation Plans URS Risk Assessments IQ/OQ/PQ Traceability Matrices Validation Summary Reports) for laboratory computerized systems and data collection platforms (databases/LIMS/PC-based instruments).
Lead and perform laboratory instrument decommissioning activities including inventory data/archive strategy chain-of-custody data migration/backup sanitization documented retirement and remediation of data integrity gaps.
Interface with QC Lab Manufacturing Engineering IT/OT and Quality to ensure timely compliant validation and decommissioning outcomes.
Assess systems for 21 CFR Part 11 compliance (audit trails security/ALCOA electronic records/signatures) and implement corrective actions.
Support change control deviations/CAPA and periodic reviews; maintain validation status through the system lifecycle.
Collaborate on PLCs industrial computers and laboratory instrumentation integrations; troubleshoot issues impacting data integrity and validated state.
Generate high-quality technical documentation in English; present results and readiness for internal/external audits.
Contribute to continuous improvement of CSV/decommissioning procedures templates and governance.

Minimum Requirements (Must-Haves)

BS or higher in Chemistry Biology Microbiology Computer Science Information Systems Engineering or related discipline.
>5 years validating laboratory computerized systems in a manufacturing environment with training in validation methodologies technologies and process control computer systems.
Demonstrated knowledge of computerized systems with data collection software (e.g. databases instrument software LIMS/ELN).
Strong working knowledge of cGMP FDA 21 CFR Part 11 and Data Integrity regulations.
Proven experience in Laboratory Instrument Decommissioning execution.
3 years working with PLCs industrial computers or laboratory instrumentation systems.
Background in pharmaceutical products manufacturing.
Excellent technical writing skills (validation/commissioning documentation) and proficiency with MS Office.
Bilingual (English/Spanish).

Preferred Qualifications

Experience with data migration/archiving tools and validated backup/restore processes.
Familiarity with QC lab systems (e.g. chromatography data systems spectroscopy particle counters balances incubators) and their integration/retirement.
Knowledge of GAMP 5 data integrity risk assessments and CSV in hybrid IT/OT architectures.
Audit support experience (FDA EMA corporate QA).

Work Conditions

Onsite role in Manatí PR with cross-functional lab/manufacturing floor interaction.
May require off-shift or weekend work during cutovers shutdowns or critical decommissioning windows.