Sr. Process Engineer at STEMCELL Technologies

The Process and Analytical Development team is looking for a highly motivated Senior Process Engineer to join our New Product Introduction & Scale-up Team.

As a Senior Process Engineer, you will be joining a highly experienced and collaborative Process Development team focused on delivering robust, cost efficient, and competitive products and manufacturing processes. You will be responsible for leading the design, qualification, and process validation effort to develop and commercialize a fully compliant cGMP nanoparticle product. This is a fantastic opportunity to apply your critical thinking skills and contribute to STEMCELL’s goal of supporting cutting edge research in the life sciences field. Successful candidates should have strong problem solving and networking skills and be able to work effectively in a dynamic and cross functional team.

Duties and Responsibilities

• Collaborate with process development and R&D scientists and engineers to develop and implement scalable, validatable, robust and reliable manufacturing, fill-finish & terminal sterilization processes
• Facilitate the seamless transition of initial designs, to scale-up, and technology transfer ensuring safety, consistency and quality throughout the product development lifecycle
• Oversee and support process equipment design and documentation, evaluation, selection, and approval of third-party equipment as required by applicable GMP manufacturing regulations
• Draft and review technical documentation, including engineering reports, risk assessments and standard operating procedures, in collaboration with Manufacturing and Quality teams
• Work collaboratively with quality, regulatory, analytical, manufacturing, procurement, and project management teams and stakeholders to ensure on budget and timely delivery of project deliverables

Knowledge and Qualifications

• A minimum of a Bachelor's degree in a relevant engineering discipline with a combination of 5-10 years of additional educational and/or professional experience
• Broad knowledge of cGMP process design, development, and implementation in a regulated industry (e.g. pharmaceuticals, biotechnology, medical devices)
• Experience developing and executing commissioning, qualification and validation protocols for pharmaceutical or biotech equipment and processes
• Experience with the practical design and operation of aseptic processes and fill-finish processes; experience in the design and validation of terminal sterilization processes of liquid products (e-beam, gamma, x-ray) would be an asset
• Competency in commonly used equipment design software (e.g. AutoCAD, SolidWorks) is an asset
• Strong verbal and written communication skills with excellent organizational skills and attention to detail