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Belcan

Validation Specialist

Greater Montreal Metropolitan Area, QC, Canada

Contract

Apply About employer

Applications open in a new tab.

Job details

Job type: Contract
Apply by: Oct 30, 2026
Posting language: English · French
Posted: Sep 30, 2026

Original job description

English section of this bilingual listing.

Are you an experienced validation professional looking to make an impact in a highly regulated biopharmaceutical environment? We are seeking a Validation Specialist to lead qualification and validation activities while supporting critical manufacturing, utility, facility, and automation projects.

What You'll Do

Lead and execute commissioning, qualification, and validation activities
Develop, author, execute, and summarize validation protocols and reports
Support utilities, facilities, equipment, process, cleaning, and automation validation projects
Provide SME support for deviations, investigations, CAPAs, and change controls
Conduct risk assessments and develop validation strategies
Review engineering drawings, design documents, and qualification packages for GMP compliance
Support audits and regulatory inspections as a validation subject matter expert
Collaborate with Quality, Engineering, Manufacturing, and Project teams to ensure successful project execution
Coach and mentor team members on validation best practices
Manage validation projects while maintaining quality, timelines, and budget expectations

What We're Looking For

✅ Bachelor's Degree in Chemical Engineering, Applied Science, or related Engineering discipline

✅ 8+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or biopharmaceutical environment

✅ Minimum 5 years of direct qualification and validation experience

✅ Experience in one or more of the following:

Utilities Qualification (Purified Water, WFI)
Facilities Qualification (HVAC, Environmental Systems)
Equipment Qualification
Automation Qualification (SCADA, HMI, PLC, BAS)
Process Validation
Cleaning Validation
Sterilization or Aseptic Process Validation

✅ Strong understanding of GMP regulations and industry guidelines (FDA, ICH, ISPE, PDA, ISO, EU GMP)

✅ Proven ability to independently manage complex validation projects and work cross-functionally

✅ Strong analytical, technical writing, and problem-solving skills

✅ Proficiency with Microsoft Office; MS Project and Visio are assets

✅ Bilingual French and English preferred

Read the full bilingual original

Spécialiste en validation

Contrat 12 mois (remplaçant pendant le congé parental)

40 heure par semaine sur site 8h-16h- peut travailler pendant les fins semaines/soire

Ville St-Laurent, QC

Industrie biopharmaceutique

Vous souhaitez mettre à profit votre expertise en validation dans un environnement biopharmaceutique hautement réglementé? Nous sommes à la recherche d’un(e) Spécialiste en Validation pour soutenir et diriger les activités de qualification et de validation liées aux équipements, utilités, installations, procédés et systèmes automatisés.

Responsabilités principales

Planifier, rédiger, exécuter et approuver les protocoles de qualification et de validation.
Participer aux activités de mise en service (commissioning), qualification et validation.
Soutenir les projets liés aux utilités, aux installations, aux équipements, à l’automatisation, aux procédés et au nettoyage.
Agir à titre d’expert technique (SME) pour les déviations, enquêtes, CAPA et contrôles de changement.
Réaliser des analyses de risques et élaborer des stratégies de validation.
Réviser les dessins d’ingénierie, les documents de conception et les dossiers de qualification afin d’assurer la conformité aux exigences GMP.
Collaborer étroitement avec les équipes de Qualité, Ingénierie, Production et Gestion de projets.
Participer aux audits et inspections réglementaires.
Encadrer et soutenir les membres moins expérimentés de l’équipe.
Assurer la réalisation des projets dans le respect des échéanciers, de la qualité et du budget.

Qualifications recherchées

✅ Baccalauréat en génie chimique, génie ou discipline connexe.

✅ Minimum de 8 ans d’expérience dans un environnement réglementé GMP.

✅ Minimum de 5 ans d’expérience en qualification et validation.

✅ Expérience dans un ou plusieurs des domaines suivants :

Qualification des utilités (eau purifiée, WFI, etc.)
Qualification des installations (HVAC, systèmes environnementaux)
Qualification d’équipements
Qualification de systèmes automatisés (SCADA, HMI, PLC, BAS)
Validation de procédés
Validation de nettoyage
Validation de procédés aseptiques et de stérilisation

✅ Connaissance des réglementations et guides de l’industrie : FDA, ICH, ISPE, PDA, ISO et EU GMP.

✅ Excellentes aptitudes en résolution de problèmes, rédaction technique et gestion de projets.

✅ Capacité à travailler de façon autonome et à coordonner des équipes multidisciplinaires.

✅ Maîtrise de la suite Microsoft Office (Word, Excel, PowerPoint). MS Project et Visio constituent un atout.

✅ Bilinguisme français/anglais fortement souhaité afin de soutenir les échanges avec des équipes et sites internationaux.

Validation Specialist

12-month contract (temporary replacement during parental leave)

40 hours per week on-site, 8 a.m.–4 p.m. - may work on weekends and evenings

St-Laurent, QC

What You'll Do

Lead and execute commissioning, qualification, and validation activities
Develop, author, execute, and summarize validation protocols and reports
Support utilities, facilities, equipment, process, cleaning, and automation validation projects
Provide SME support for deviations, investigations, CAPAs, and change controls
Conduct risk assessments and develop validation strategies
Review engineering drawings, design documents, and qualification packages for GMP compliance
Support audits and regulatory inspections as a validation subject matter expert
Collaborate with Quality, Engineering, Manufacturing, and Project teams to ensure successful project execution
Coach and mentor team members on validation best practices
Manage validation projects while maintaining quality, timelines, and budget expectations

What We're Looking For

✅ Bachelor's Degree in Chemical Engineering, Applied Science, or related Engineering discipline

✅ 8+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or biopharmaceutical environment

✅ Minimum 5 years of direct qualification and validation experience

✅ Experience in one or more of the following:

Utilities Qualification (Purified Water, WFI)
Facilities Qualification (HVAC, Environmental Systems)
Equipment Qualification
Automation Qualification (SCADA, HMI, PLC, BAS)
Process Validation
Cleaning Validation
Sterilization or Aseptic Process Validation

✅ Strong understanding of GMP regulations and industry guidelines (FDA, ICH, ISPE, PDA, ISO, EU GMP)

✅ Proven ability to independently manage complex validation projects and work cross-functionally

✅ Strong analytical, technical writing, and problem-solving skills

✅ Proficiency with Microsoft Office; MS Project and Visio are assets

✅ Bilingual French and English preferred

Apply About employer

More about this job

Responsibilities

Lead and execute commissioning, qualification, and validation activities for utilities, facilities, equipment, processes, cleaning, and automated systems, including authoring protocols and reports and developing risk-based validation strategies. Provide subject matter expertise for deviations, investigations, CAPAs, change controls, audits, and inspections while collaborating across teams and managing project quality, timelines, and budgets.

Requirements

Requires a bachelor's degree in chemical engineering, applied science, or a related engineering discipline, at least eight years of GMP-regulated industry experience, and at least five years of direct qualification and validation experience. Candidates should understand relevant GMP regulations and industry guidelines, have strong project management, analytical, and technical writing skills, be proficient with Microsoft Office, and preferably be bilingual in French and English.

Skills

Commissioning
Qualification
Validation
GMP Compliance
Utilities Qualification
Facilities Qualification
Equipment Qualification
Automation Qualification
Process Validation
Cleaning Validation
Aseptic Process Validation
Sterilization Validation
Risk Assessment
Deviation and CAPA Management
Technical Writing
Project Management

Visa sponsorship

Not detected in the job text

Keywords

Biopharmaceutical
GMP
FDA
ICH
ISPE
PDA
ISO
EU GMP
Commissioning
Qualification
Validation Protocols
Validation Reports
Risk Assessment
CAPA
Change Control
Deviation Investigations
Purified Water
Water For Injection
HVAC
Environmental Systems
SCADA
HMI
PLC
BAS
Process Validation
Cleaning Validation
Aseptic Processing
Sterilization
Microsoft Office
MS Project

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