Job Details
Location: Ottawa, Ontario, Canada
Salary: Not specified
Company: ApnaWorker
We are seeking an experienced Contamination Control and Cleaning Validation Subject Matter Expert (SME) to support GMP cleanroom remediation and improvement initiatives within a sterile pharmaceutical or biotechnology manufacturing environment. Key responsibilities include performing contamination control and cleaning program gap assessments, improving cleanroom disinfection practices, evaluating disinfectant selection and rotation, and enhancing Environmental Monitoring (EM) programs. The successful candidate will identify GMP compliance gaps aligned with Health Canada, FDA, and EU GMP Annex 1, develop remediation plans, and update SOPs and validation documentation. Requirements include over 8 years of experience in contamination control within pharma/biotech GMP or sterile manufacturing, deep knowledge of aseptic environments, and strong technical documentation skills. Experience with sterile injectables, biologics, or vaccine manufacturing is preferred.