Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.The Validation Specialist will assist with defining and creating validation processes for all existing and new equipment; ensuring the processes are in line with best practice and evolving regulatory expectations. Responsibilities:  Assess and examine current validation processes and recommend process improvements including developing, documenting, and implementing protocols and proceduresWork closely with all departments ensuring the operation of a validated environment according to GMP and other regulatory requirementsOrganize documentation and local execution of method transfersDefine, support and guide validation activities both internally and for external suppliersProvide product validation guidance relating to activities needed for new product launchesProvide validation and technical direction to lead project teams as neededDevelop/review and approve validation protocols and final reports and ensure compliance with GMPs and current regulatory requirementsAssist with coordination of hold-time studies, cleaning studies, and re-validation/qualification activities for the siteDrive best practices toward continued or continuous process validation (CPV)Champion/promote validation best practices and health authority expectationsPartner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol executionCreate and write validation protocols, directives, SOPs, and reports as required and review for technical validationReview change requests for impact to validation and support QA compliance activities such as Product Quality ReviewPerform trending analysis, as required, as part of routine monitoring and/or validation activitiesWork with team members in the maintenance of the facility’s validation programServe as a Subject Matter Expert (SME) within the facility based on area of knowledge and associated value stream.Skills and Qualifications:Thorough knowledge and understanding of validation requirements in a GMP facility and Validation Lifecycle ApproachCompetent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standardsStrong communication skills both verbally and writtenAbility to "get things done" without compromising principles. A high level of energy and strong work ethic is critical to successExperience in a pharmaceutical/manufacturing environment, along with a relevant degreeUnderstanding of validation requirements across multiple categories (generalist)Experience in a pharmaceutical/manufacturing environmentRelevant science degree 

Validation Specialist

Located in Barrie, Ontario, MediPharm Labs offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, named Start-Up of the Year at the most recent Canadian Cannabis Awards. Our growing team of scientists, technicians, engineers and business professionals delivers quality and innovation through research, discipline, and forward thinking.

The Validation Specialist will assist with defining and creating validation processes for all existing and new equipment; ensuring the processes are in line with best practice and evolving regulatory expectations. 

Responsibilities:  

  • Assess and examine current validation processes and recommend process improvements including developing, documenting, and implementing protocols and procedures
  • Work closely with all departments ensuring the operation of a validated environment according to GMP and other regulatory requirements
  • Organize documentation and local execution of method transfers
  • Define, support and guide validation activities both internally and for external suppliers
  • Provide product validation guidance relating to activities needed for new product launches
  • Provide validation and technical direction to lead project teams as needed
  • Develop/review and approve validation protocols and final reports and ensure compliance with GMPs and current regulatory requirements
  • Assist with coordination of hold-time studies, cleaning studies, and re-validation/qualification activities for the site
  • Drive best practices toward continued or continuous process validation (CPV)
  • Champion/promote validation best practices and health authority expectations
  • Partner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol execution
  • Create and write validation protocols, directives, SOPs, and reports as required and review for technical validation
  • Review change requests for impact to validation and support QA compliance activities such as Product Quality Review
  • Perform trending analysis, as required, as part of routine monitoring and/or validation activities
  • Work with team members in the maintenance of the facility’s validation program
  • Serve as a Subject Matter Expert (SME) within the facility based on area of knowledge and associated value stream.

Skills and Qualifications:

  • Thorough knowledge and understanding of validation requirements in a GMP facility and Validation Lifecycle Approach
  • Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards
  • Strong communication skills both verbally and written
  • Ability to "get things done" without compromising principles. A high level of energy and strong work ethic is critical to success
  • Experience in a pharmaceutical/manufacturing environment, along with a relevant degree
  • Understanding of validation requirements across multiple categories (generalist)
  • Experience in a pharmaceutical/manufacturing environment
  • Relevant science degree 

To apply online, please click on the appropriate link below.