Senior CSV Validation Engineer - Pharma industry

@ ALGOBRAINZ

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Ontario

Contrat6+ ans d’expérience

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SIGNAUX

En bref

ALGOBRAINZ, on behalf of its client, is hiring a Senior CSV Validation Engineer on a contract basis for an on-site role in a regulated Ontario pharmaceutical manufacturing site. The role leads computer system validation of Building Management Systems across all buildings, from URS through the Validation Summary Report and closeout. Candidates need 6+ years of experience validating building management or control systems in a GMP environment.

Responsabilités :

Lead BMS validation lifecycle from URS to closeout
Develop and execute DQ, IQ, OQ and PQ protocols
Author RTMs and Validation Summary Reports
Perform 21 CFR Part 11 gap assessments on Metasys and AVEVA PI
Validate OPC UA integrations between Metasys, AVEVA PI and DeltaV

Résumé des exigences :

6+ years of CSV experience in GMP building management systems
Working knowledge of GAMP 5 and risk-based validation
Hands-on 21 CFR Part 11 compliance experience
Knowledge of FDA and EMA computerized system expectations
Familiarity with ISA 18.2 and ISA IEC 62443

Outils et compétences

Johnson Controls Metasys AVEVA PI Historian DeltaV OPC UA

Source et dates

Type de source non vérifié · apify-linkedin

Date publiée par l’employeur: 2026-10-16
Première détection par notre source: 2026-11-11
Mise à jour du dossier source: 2026-11-11

Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.

Détails du poste

Niveau	Senior
Domaine	Développement logiciel
Expérience	6 an(s) et plus
Déplacements	avion : aucun · route : aucun
Milieu de travail	Bureau, Usine
Position	Assis et debout
Exigences physiques	physique faible · ordinateur élevé
Langues	English

Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.

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ALGOBRAINZ

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Offres sur Jobsy	4

Description

Title: Senior CSV Validation Engineer

Industry: Pharmaceutical

Location: Ontario, Canada

Experience: 6+ years

Job Summary:

Our client is seeking a Senior CSV Validation Specialist dedicated to Building Management System validation activities. This is an on-site role supporting a regulated pharmaceutical manufacturing environment. The role supports the Site Automation Engineering organization and works closely with automation engineers, IT, system integrators, and site leadership to ensure systems are validated and maintained in a compliant state.

Roles & Responsibilities:

Lead the Building Management System validation lifecycle across all buildings from User Requirement Specification authoring through Validation Summary Report and closeout.
Develop and execute Design Qualification, Installation Qualification, Operational Qualification, and Performance Qualification protocols using a risk-based approach aligned with quality procedures.
Generate and maintain Requirements Traceability Matrices linking requirements through design, testing, and acceptance.
Author Validation Summary Reports documenting validation activities, deviations, resolutions, and acceptance rationale.
Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across Metasys and AVEVA PI systems.
Coordinate with Integration Engineering resources to support alarm management validation aligned with ISA 18.2 and operational technology cybersecurity validation aligned with ISA IEC 62443.
Validate OPC UA integrations between Metasys, AVEVA PI, and DeltaV.
Draft and maintain Standard Operating Procedures related to Building Management System operations, operator training, and preventive maintenance.
Enroll validated systems into the periodic review program to support ongoing maintenance of the validated state.
Support audit readiness activities by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and corporate quality standards.
Provide additional support for data integrity assessments, commissioning and qualification activities, remediation of validation findings, and validation strategy development for future system upgrades as needed.

Required qualifications:

Demonstrated experience performing computer systems validation for building management or control systems within a pharmaceutical or GMP-regulated environment.
Strong working knowledge of GAMP 5 methodology, V model lifecycle concepts, and risk-based validation approaches.
Hands-on experience supporting 21 CFR Part 11 compliance assessments for electronic records, electronic signatures, and audit trails.
Solid understanding of FDA and EMA regulatory expectations related to computerized system validation.
Direct experience validating Johnson Controls Metasys, Honeywell, Siemens, or similar Building Management System platforms.
Experience validating AVEVA PI Historian, DeltaV systems, or OPC UA integrations.
Familiarity with ISA 18.2 alarm management principles and ISA IEC 62443 cybersecurity standards.
Knowledge of data integrity principles, including ALCOA plus and data governance practices.