Head of Technical Services (Processes, Engineering, and Validation)

Our client is a company specializing in the development, the manufacture, and the international marketing of pharmaceutical products used in diagnostics, treatment, and the monitoring of illnesses. They are currently looking for a Head of Technical Services.

Nature of position

Under the supervision of the Head of Manufacturing Operations, you will act as an expert and technical reference for the full range of activities and issues related to products, manufacturing processes, production systems and equipment (improvement and optimization projects), for all products manufactured in-house or externally, as well as coordinating matters of validation and calibration.

• Develop and maintain the expert knowledge and technical skills required for products, processes, medical instruments, systems, and equipment related to the company’s range of products (manufactured in-house and externally [CMO];
• Provide technical support for routine manufacturing of commercial products;
• Provide a technical perspective, troubleshooting, and an expert opinion in problem solving with various departments and project teams;
• Collect and analyze data using the appropriate statistical tools in order to make solid recommendations / decisions;
• Liaise with R&D when additional development activities or additional data are required to maintain troubleshooting or product/process improvement activities;
• Actively support the quality through product design approach and the development process and make sure process and product knowledge is shared between the R&D department and production (in-house or external);
• Manage projects;
• Regularly control the performance of the product portfolio and lead or participate in various continual improvement or optimization projects (increasing capacity, site transfer, productivity improvements, or transfer of new products);
• Support the project management’s implementation of best practices (tools and processes) and make sure you are on the same page as the operations team;
• Support the implementation and intensive use of Good Engineering Practices (GEP), risk evaluation (for example, FMEA), as well as continual improvement and manufacturing techniques;
• Validation and calibration;
• Develop, maintain, and supervise the implementation of the comprehensive validation program (including requalification) for computer equipment and related systems, installations, medical instruments, manufacturing processes, and cleaning activities (except analytical validation);
• Review calibration, validation, and maintenance programs with a view to improving and optimizing the strategy while striking an appropriate balance between operational efficiency and compliance needs;
• Liaise with the sister company as much as is needed regarding shared equipment and the validation of the system. Make sure the responsibilities required by the company are met;
• Revise as needed and approve documentation (validation protocols / reports, master plans, etc.) and see to it that these documents are compliant with good manufacturing practices (GMP) and in-house regulations;
• You will be responsible for defending the programs and all the protocols and reports produced in the event of regulatory inspections and internal audits;
• Provide support for regulatory changes by supplying the required validation and change control documents;
• Carry out any other task related to your duties.

Required qualification

• Bachelor of Engineering in a relevant field (chemical, mechanical, biochemical, or related) or Bachelor of Science (chemistry, biochemistry, or related fields);
• Significant work experience in the pharmaceutical sector;
• Excellent written and spoken communication skills in English and French;
• Good technical knowledge of processes, improvements to processes, troubleshooting, and managing capitalization projects;
• Well-acquainted with various statistical tools and with GMP;
• Able to interact with multidisciplinary teams, to plan, to manage priorities, and to solve problems;
• Knowledgeable of pharmaceutical validation (an asset);
• Proficient with standard computer software.

Education / training

Bachelor in biochemistry, Bachelor in biology, Bachelor in chemical engineering , Bachelor in chemistry, Bachelor in industrial engineering , Bachelor in mechanical engineering

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