Job Description

The Centre for Probe Development and Commercialization (CPDC) is a global leader of next-generation radiopharmaceuticals. At CPDC we are working with our partners to discover, develop and distribute the next generation of imaging agents and targeted radiotherapeutics for the detection and treatment of human diseases such as cancer.
Our Centre has the full range of scientific, technical, regulatory and business expertise combined with specialized infrastructure required to translate radiopharmaceuticals from clinics to the commercial marketplace. Radiopharmaceuticals are perishable products that require just-in-time manufacturing. CPDC's success in the radiopharmaceutical industry results in the ability of our talented staff to develop reproducible processes that yield high quality products while adhering to international regulations governing nuclear safety, transportation of goods, and pharmaceutical manufacturing. Our staff takes pride in the impact we make every day in the lives of patients across the globe.
About the Role:
As an Intern- Engineering Technician and Coordinator, you will work closely with the Director and Engineering Supervisor to coordinate and drive validation and calibration protocol, planning and execution. You will drive project initiatives for continual improvement within the department. The position is an individual contributor that is expected to interact with individuals from different disciplines (Engineering, QC, Operations, and Quality) to plan, execute, and complete validation and calibration activities.
Job Responsibilities:

• Assist with vendor calibration programs and internal calibration programs, along with review and approval of service records and reports (i.e. certificates of calibration, executed protocols, work orders and vendor reports, for completeness and accuracy.
• Coordinate the calibration and maintenance of manufacturing, analytical and process equipment within the Centre, including, but not limited to, clean rooms, HEPA filters, Hotcells, balances, etc.
• Work across groups and sites, ensure calibration and maintenance programs are established and maintained in compliance with cGMPs and the Validation Plan
• Co-ordinate and work with the production teams to ensure that calibration and preventative activities do not impact production schedules
• Assure completion of documentation, as required, for existing and new equipment into the calibration/maintenance programs
• Assist Engineering and maintenance teams with tasks including, but not limited to, participating as verifier in smoke study tests in Grade A Hotcells, BSC's and Isolators.
• Assist in generating deviations for items found to be beyond acceptable limits
• Assist in writing SOP's, protocols and controlled forms related to calibration, routine use and preventative maintenance of equipment and facilities
• Co-ordinate with the Engineering supervisor and technicians to assure that management and QA are informed of compliance status and adherence to commitments
• Work closely with the Engineering Supervisor to prepare and drive change controls in relation to continuous improvement projects for the department.
• Work closely with the project manager and project coordinator at CPDC to schedule in Engineering activities and tasks in relation to ongoing CPDC projects that need engineering assistance.
• Assist in preparing, reviewing and executing Validation Protocols addressing all critical functionality and limits for equipment and processes required to be validated (IQ/OQ/PQ)
• Assist in writing validation reports that summarize and assess impact of the results generated
• Interact with individuals from different disciplines (Engineering, Laboratory, Operations, and Quality) to plan, execute, and complete validation activities
• Perform risk assessment exercises in support of validation activities
• Document validation plans and protocols (tests) to provide objective evidence that equipment meet requirements and are compliant with applicable regulations
• Ensures compliance with Health, Safety and Environment protection rules, with engagement of all associates to apply the policies, procedures and regulations applicable to their work.
• Demonstrate safety knowledge, awareness and compliance with all safety and other job related policies and procedures
• Other duties as assigned by area management

Required Education/Experience/Knowledge:*
Enrolled in Engineering related or discipline.

• Minimum 1 year of proven pharmaceutical or relevant experience managing equipment with direct impact to product testing and quality
• Technical report writing, ability to understand and analyze technical systems and trends
• Familiarity with appropriate GMP compliance requirements of pharmaceutical industry
• Strong interpersonal and project management skills; must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.
• Expertise in Microsoft Office applications, including Word and Excel, and data entry experience.
• Ability to work both independently and in partnership with others.
• Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration and accountability are valued
• Ability to work independently and possess excellent organizational skills
• Demonstrated ability to successfully prioritize, manage time well, multitask, and troubleshoot
• Knowledgeable in use of spreadsheets, database, and word processing software
• Strong computer skills with the ability to rapidly input data and retrieve records and information; good reporting skills.
• Ability to lift 23 kilograms required

*
CPDC Offers: **
Competitive compensation

• Opportunity for long-term growth
• Professional, collaborative environment
• Innovative and interesting work that makes a positive impact on patients and Canadian healthcare

If you require accommodation for your application or interview, please contact Human Resources directly at 905.525.9140 ext. 21112 or by email at careers@imagingprobes.ca
We thank all those who apply but only candidates selected for interviews will be contacted.Job Types: Internship, Apprenticeship