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Process Engineering Specialist

Teva Pharmaceuticals
3 days ago
On-site
Whitchurch-Stouffville, ON, Canada
Indeed

We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Our Team, Your Impact We are currently seeking a Process Engineering Specialist to join our Manufacturing Science & Technology (MS&T) team. In this role, you will play a key part in pharmaceutical product development, process optimization, technology transfer, validation activities, and continuous improvement initiatives that support the manufacture of high-quality medicines. This is an exciting opportunity for a scientifically driven professional who thrives in a cross-functional environment and enjoys solving complex technical challenges throughout the product lifecycle. How You’ll Spend Your Day Formulation & Product Development Design, develop, and optimize pharmaceutical formulations and dosage forms. Support product lifecycle management, reformulation projects, and alternate supplier qualifications. Evaluate product performance, stability, potency, purity, content uniformity, and dissolution characteristics. Support regulatory submissions through technical documentation review and data analysis. Process Development & Technology Transfer Develop, evaluate, and optimize manufacturing processes for pharmaceutical products. Lead and support scale-up, site transfer, commercialization, and technology transfer activities. Participate in equipment qualification and process validation activities, including IQ, OQ, and PQ. Analyze manufacturing performance data and identify opportunities for process improvements, yield enhancement, waste reduction, and cost savings. Quality & Compliance Ensure compliance with GMP, Health Canada, FDA, and other applicable regulatory requirements. Review and approve Change Controls, Master Batch Records, manufacturing instructions, and quality documentation. Conduct technical investigations, root cause analyses, and CAPA activities related to product and process deviations. Assess the impact of formulation, process, material, and equipment changes on product quality and regulatory compliance. Cross-Functional Collaboration Partner closely with Quality Assurance, Regulatory Affairs, Manufacturing, Validation, and Supply Chain teams. Participate in Technical Review Meetings and provide project updates, risk assessments, and technical recommendations. Act as a technical resource and subject matter expert for internal stakeholders and project teams. Manage multiple projects while balancing shifting priorities and business needs. Your Skills and Experience Bachelor's degree in Pharmacy, Chemical Engineering, or a related scientific discipline. Preferred: Master's degree in Pharmacy, Chemical Engineering, or a related scientific discipline. 5+ years of experience in pharmaceutical product development, formulation development, technology transfer, process validation, and/or manufacturing support. Proven experience with solid oral dosage forms and controlled-release products. Strong understanding of GMP requirements, pharmaceutical manufacturing, and product lifecycle management. Knowledge of Canadian, U.S., and international regulatory requirements and quality standards. Strong scientific and technical problem-solving abilities. Excellent written and verbal communication skills. Ability to write technical reports, protocols, and development documentation. Strong presentation and stakeholder management skills. Ability to prioritize multiple projects and meet deadlines in a fast-paced environment. Leadership skills with the ability to influence and…

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