About the Company
PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up.
PharmEng Technology has offices in various locations including Canada, America and Asia. We’ve got projects across Canada, USA, Europe and Asia.
Roles and Responsibilities:
- Authors and executes related project documentation for installation, operation and performance qualifications of manufacturing equipment (Air Handling System)
- Author and executes related project documentation for process validation studies
- Participates on cross functional project teams as validation representative. Responsible for action items and deliverables as determined by project team
- Reviews validation documentation for completeness and accuracy
- Support development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines
- Author assigned Standard Operating Procedures (SOPs) to ensure compliance with Company policies and federal regulations
- Manage multiple projects with strong organizational skills and prioritization
- Support continuous improvement within the Validation department
- Other duties as assigned
- Minimum Bachelor of Science or Engineering in relevant field.
- At least 4 years experience in validation, engineering and/or quality assurance in the Pharmaceutical and Biotech industry.
- Working knowledge of regulations(cGMP-FDA 21CFR 210/211, 600 and/or part 11, Health Canada GMPs, GAMP, and other related regulations ie. GLP, GCP, ISO etc).
- Strong working knowledge of Microsoft Office applications.
- Excellent communication skills both written and oral, organizational and technical skills with problem solving ability.
- Management of assigned tasks and projects with minimal supervision.
- Willingness to travel
- Holds a valid driving license and passport
- Must be able to legally work in Canada