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Your are admissible to the short term disability plan (STD) after having completed three (3) months of continuous service as a permanent employee.
Your are admissible as of your first day of employment. 1) Eye examination once every 24 months2) glasses and prescritpion: $200/24 months for adults and $200/12 months for children under 18 years old.
- Build and maintain extensive technical knowledge and expertise for all Jubilant Draximage products, process and equipment. This includes non-radioactive (ex: freeze dried products) and radioactive products manufactured internally and externally (CMOs).
- Provide technical support for commercial products during routine manufacturing.
- Provide technical acumen, troubleshooting and problem solving expertise to various departments and project teams.
- Collect and analyse data using appropriate statistical tools in order to make sound data driven recommendations/decisions.
- Liaise with R&D when additional development activities or supplementary data are required to support troubleshooting or process/product improvement activities.
- Develop and implement a systematic technology transfer approach and methodology for new and commercial product transfer on site or at CMOs.
- Actively support Quality by Design approach in product and process development and ensure smooth process and product knowledge transfer between R&D and production (internally or at CMOs).
- Actively support operations and quality team for investigation and impact assessment writing
- In collaboration with Health and safety, ensure to complete safety analysis before new equipement or new process introduction
- Oversee current Calibration and Preventive Maintenance programs with his responsible maintenance supervisors
- Review and formulate department’s preventive maintenance, calibration, qualification and validation plans and standard operating procedures
- Review URS and specifications for new equipment
- Prepare and participate to call of tenders
- Ensure supervision and planning of new equipment installation
- Ensuring compliance of the engineering practices with the current GMP requirements and industry’s best practices.
- Regularly review the product portfolio performance and lead or participate to various optimization or continuous improvement projects (scale-up, site transfer, yield improvement or new product transfer).
- Support the deployment of project management best practices (tools and processes) aligned with the rest of the Operations teams.
- Support the implementation and extensive use of engineering best practices (GEPs), risk assessments (e.g. FMEA) as well as continuous improvement and lean manufacturing techniques.
- Build and maintain successful cross-functional relationships with internal customers such as Production, Supply Chain, PMO, Quality and R&D departments.
- Supports cross-functionally colleagues and teams in various cross-functional projects or due diligence efforts requiring technical skills or validation support.
- Establish and monitor Key Performance Indicator for the department.
- Coach the team to ensure professional development of employees, in particular strong technical knowledge and project management skills, and knowledge redundancy among the team.
- Prioritize team efforts in order to maximize objectives and coordinate the tasks of the team in order to fulfill the department objectives.
- Ensure appropriate filing and archiving practices for all technical documentation (validation, calibration/maintenance and projects).
- Respect the union agreement and adequately address employee’s inappropriate performance and behavior.
- Performs additional duties as assigned by Management.
- Bachelor’s Degree in Engineering (Chemical, Mechanical, Biochemical or related field) or in Science (Chemistry, Biochemistry or related field).
- Minimum 10 years of experience in the pharmaceuticals environment with at least 5 years in technical services and validation.
- Minimum 3 years supervision experience.
- Member OIQ
- Experience with radiopharmaceuticals (an asset).
- Sound process oriented technical knowledge.
- Good working knowledge of various statistical tools.
- Demonstrated evidence of process improvements and troubleshooting expertise.
- Knowledge of Quality by design and stage gate process (an asset).
- Sound project management experience with multidisciplinary teams.
- Working knowledge of GMPs (Canadian, USA and European).
- Sound technical acumen and problem identification and solving capabilities.
- Good analytical skills and detailed oriented.
- Acute planning, prioritizing and multitasking skills.
- Proactive and result oriented.
- Excellent collaborative leadership, interpersonal skills and team work approach.
- Ability to perform under pressure.
- Excellent communication skills.
- Ability to interact efficiently in a cross-functional team.
- Proficiency in Microsoft Office (MS project an asset).
- PMP certification (an asset).
- Excellent written and spoken (French and English) communication skill.
Fr : Advanced
En : Advanced
Internal reference No. Senior Manager, Manufacturing Science an
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