Job Description

Resume du poste :

Superviser et maintenir un programme complet de surveillance environnementale (EM) afin d'assurer la conformite reglementaire et des conditions controlees en production pharmaceutique.

Principales responsabilites :

Coordonner et gerer les activites quotidiennes du programme EM conformement aux BPF et aux reglementations canadiennes, americaines et europeennes. Mettre a jour et optimiser les protocoles EM selon les changements reglementaires et les meilleures pratiques du secteur. Realiser des inspections et parcours reguliers des zones classifiees pour garantir le respect des SOP et des exigences reglementaires. Fournir un soutien technique sur les operations aseptiques et les strategies de controle de la contamination. Analyser les tendances des donnees EM, realiser des evaluations de risques et mettre en oeuvre des actions correctives pour maintenir le controle operationnel. Participer a la requalification des systemes EM afin de maintenir des conditions de fabrication validees. Collaborer avec les equipes Qualite, Production et R&D sur les initiatives EM.

Competences et experience requises :

Diplome en microbiologie, sciences de la vie ou domaine connexe, ou experience pratique equivalente. Minimum de 5 ans d'experience pratique avec les programmes EM et tests microbiologiques dans un environnement pharmaceutique ou de soins de sante reglemente. Solide connaissance de la fabrication sterile, validation des equipements et controle qualite. Expertise en conformite BPF (cGMP) selon les reglementations canadiennes, americaines et europeennes. Excellentes competences en communication, resolution de problemes et collaboration interfonctionnelle.

Mots-cles :

Surveillance environnementale, BPF, fabrication sterile, validation, controle de contamination, microbiologie, production pharmaceutique, controle qualite

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Position Overview:

Lead and maintain a comprehensive Environmental Monitoring (EM) program to ensure regulatory compliance and controlled conditions in pharmaceutical manufacturing.

Key Responsibilities:

Coordinate and oversee daily EM program activities in compliance with cGMP and regulatory standards (Canada, U.S., EU). Update and optimize EM protocols to reflect regulatory changes and industry best practices. Conduct routine inspections and walkthroughs of classified areas to ensure SOP and regulatory adherence. Provide technical guidance on aseptic operations and contamination control strategies. Monitor EM data trends, perform risk assessments, and implement corrective actions to maintain operational control. Support EM system requalification to sustain validated manufacturing conditions. Collaborate cross-functionally with Quality, Production, and R&D teams on EM-related initiatives.

Qualifications & Experience:

Degree in Microbiology, Life Sciences, or related field, or equivalent practical experience. 5+ years hands-on experience with EM programs and microbiological testing in regulated pharmaceutical or healthcare environments. Strong knowledge of sterile manufacturing, equipment validation, and quality control. Expertise in cGMP compliance across Canadian, U.S., and EU regulations. Excellent communication, problem-solving, and cross-functional collaboration skills.

Keywords:

Environmental Monitoring, cGMP, sterile manufacturing, validation, contamination control, microbiology, pharmaceutical production, quality control

Job Type: Full-time

Work Location: In person