Role: Sr. Contamination Control / Cleaning SME Location: Ottawa, Ontario, Canada (Onsite) Duration: Long term (W2) Start date : ASAP

We are looking for an experienced Senior Contamination Control / Cleaning Subject Matter Expert (SME) to join a leading pharmaceutical consulting team in Ottawa, Ontario, Canada. If you have strong expertise in contamination control, cleaning validation, and GMP compliance within sterile manufacturing environments, we would like to connect with you. Position Details Role: Sr. Contamination Control / Cleaning SME Location: Ottawa, Ontario, Canada (Onsite) Key Responsibilities Lead contamination control, cleaning validation, and disinfection program remediation initiatives Perform gap assessments against GMP regulations, Annex 1, FDA, EMA, MHRA, and ICH guidelines Develop and implement cleaning validation strategies, SOPs, protocols, and remediation plans Review disinfectant qualification, efficacy studies, cleaning procedures, and environmental monitoring programs Lead investigations related to contamination events, cleaning failures, and CAPAs Support qualification and validation of cleaning agents and disinfectants Collaborate with QA, Manufacturing, Validation, Microbiology, and Regulatory Affairs teams Support regulatory inspections, audits, and continuous GMP compliance improvements Required Qualifications Bachelor's or Master's degree in Microbiology, Biology, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related field 8+ years of experience in contamination control, microbiology, cleaning validation, or quality systems within pharmaceutical, biotechnology, vaccine, or sterile manufacturing environments Strong knowledge of cGMP, EU GMP Annex 1, FDA, EMA, MHRA, and ICH guidelines Expertise in Cleaning Validation, Contamination Control, Disinfectant Qualification and Efficacy Studies, Environmental Monitoring, Aseptic Processing, and CAPA and Compliance Remediation Preferred Qualifications Experience supporting regulatory inspections and remediation programs Knowledge of risk-based contamination control strategies and modern Annex 1 requirements Experience in sterile manufacturing, biologics, vaccines, or cell and gene therapy Professional certifications in Contamination Control, Microbiology, or Quality Systems are a plus.