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Task description and requirements

• Lead cleaning validation studies, including protocol development, execution, and report writing, to ensure the effectiveness of cleaning processes for pharmaceutical manufacturing equipment and facilities.
• Conduct risk assessments and gap analyses to identify areas for improvement and implement corrective and preventive actions (CAPAs) as necessary.
• Perform routine monitoring and trend analysis of cleaning validation data to maintain process integrity and address deviations or non-conformances.
• Collaborate with Quality Assurance, Manufacturing, and Engineering teams to establish cleaning procedures, validate cleaning methods, and qualify cleaning agents and equipment.
• Provide technical expertise and guidance on cleaning validation-related issues during regulatory inspections and audits.
• Stay abreast of industry trends, regulatory requirements, and best practices related to cleaning validation and contribute to the development of company standards and policies.

• Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering, or related field; advanced degree preferred.
• Minimum of 6 years of experience in cleaning validation within the pharmaceutical or biotechnology industry.
• Experience working with liquid dosage is an asset.
• Strong understanding of cGMP regulations, FDA guidelines, and international regulatory requirements related to cleaning validation.
• Proficiency in data interpretation, and report writing.
• Excellent communication and interpersonal skills with the ability to collaborate effectively across functional teams.
• Detail-oriented with strong problem-solving skills and a commitment to quality and compliance.

• Dental care
• Extended health care
• Flexible schedule
• On-site parking
• Profit sharing
• RRSP match
• Vision care

• French not required

• Monday to Friday

• Overtime pay

• Bachelor's Degree (preferred)

• Pharmaceutical: 6 years (preferred)
• Cleaning Validation: 6 years (preferred)

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