Validation Lead - London, Ontario or Remote
Temporary for 12 months
Tilray is a global pioneer in cannabis research, cultivation, processing and distribution currently serving tens of thousands of patients in ten countries spanning five continents.
About High Park Company
High Park Company was established to develop, sell, and distribute inspiring and iconic adult-use cannabis brands.
Looking to develop your career at the forefront of a rapidly expanding industry?
Reporting to the Sr. Quality Manager, the Validation Specialist is responsible for providing expertise and guidance with regards to regulatory requirements and best practices related to process validation, equipment qualification, and computerized systems validation as well as providing support for the quality processes and procedures at Tilray and High Park, Canada.
Role and Responsibilities
Develop and maintain the Site Validation Master Plans for compliance with company and regulatory requirements.
Reviews validation strategies and associated documentation against the requirements of the Validation Master Plan, to ensure that compliance and business needs are achieved.
Reviewer and approver of:
Process Validation (PV) related protocols, reports and other documents.
Commissioning documents, SATs, FATs, qualification protocols and reports (IQ/OQ/PQ), Equipment & Facility Change Controls,
Assess impact on validation of Calibration/Facility related failure Investigation.
Cleaning Validation (CV) related protocols, reports and other documents.
Computer System Validation (CSV) related protocols, reports and other documents.
Develop and execute Process Validation Protocols and Reports, ensuring that the manufacturing and packaging processes are maintained in a validated state of control. Provides notification of discrepancies and/or concerns to site leadership.
Develop and execute Cleaning Validation Protocols and Reports, ensuring that the cleaning of equipment is maintained in a validated state of control. Provides notification of discrepancies and/or concerns to site leadership.
Performs technical assessments, to determine impact of changes to the Validation status, using the appropriate change control procedures.
Validation SME for reviews/approvals of proposed remedial and corrective actions related to deviation investigation and other excursions related to out of trend/specification of validation/qualification data, as required. Ensure that any proposed CAPA are appropriately assessed for validation impact.
Acts as a member of teams and/or committees for new product launches and change controls to provide guidance related to validation regulations/guidelines.
Oversees cleaning failures at a Site level and ensures deviation investigations are initiated following existing procedure, as required.
As applicable, reviews change controls for Production, Manufacturing, and Packaging records for the appropriate validated parameters and supporting documentation. Reviews and approves impact of changes to the validation status, according to the applicable change control procedures.
Provides training on Process Validation, Equipment & Facility Qualification, Cleaning Validation and Computer System Validation topics to the site operations, quality, engineering and facilities team as required.
Ensures that all work is performed in full compliance with the Cannabis Regulations, Good Manufacturing Practices and SOPs.
Other duties as assigned
BS/BA in Engineering, Chemistry, or Life Sciences
4+ years related experience within the field preferred; may substitute relevant experience for education
Strong knowledge of GMPs for pharmaceuticals/biotechnology
Must be willing and able to travel between the Tilray Canada and High Park facilities
Ability to work independently and as part of a team
Ability to comprehend regulatory requirements and technical documentation
Excellent written and oral communication skills
Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems
Detailed knowledge of application of quality management systems
Competent knowledge of facility/utility/equipment/process/cleaning/computer systems qualification, new production introduction and commercial manufacture for pharmaceutical manufacturing facilities
Capable of troubleshooting/problem solving on issues associated with projects, process development etc.
Tilray welcomes applications from all qualified individuals and is committed to employment equity and diversity in the workplace.
Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application.
Please note that Tilray does not authorize, engage, or sponsor any consultants, agencies or organizations that seek certain personal or financial information from you (e.g. passwords, login ids, credit card information). The Company does not charge any application, processing or onboarding fee at any stage of the recruitment or hiring process.
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