What are the responsibilities and job description for the Process Engineer position at Katalyst CRO?
Responsibilities
- Support activities within MSAT-US, including the development of technical documentation, SOPs, and internal systems.
- Provide technical expertise in packaging and Pharma processes, equipment, materials, and component performance.
- Investigate and recommend new packaging technologies, systems, and materials for potential integration into Company packaging and Pharma manufacturing systems.
- Provide project management support for CMC and packaging projects related to late-stage NCE development, Life Cycle Management Programs (LCM), and Commercial Products.
- Collaborate with cross-functional teams (R&D, Marketing, Regulatory, QA, etc.) to develop project strategies and objectives.
- Lead or support the qualification of process and packaging equipment, including primary and secondary equipment, and transport systems for bulk/intermediates and finished products.
- Develop test protocols and manage the execution of studies such as transport qualification for bulk and finished drug products.
- Act as a technical and coordination focal point for multi-site projects involving CMOs and internal teams.
- Identify and recommend new processes and technologies that improve cost, compliance, and quality.
- Represent Manufacturing & Supply in the development, qualification, and launch of new products.
- Support the evaluation of primary packaging material systems for individual project objectives.
- Make recommendations on equipment and new drug product stability programs based on product protection, performance, and cost considerations.
- Demonstrate comprehensive knowledge of solid and liquid oral processes and packaging material types and their technical performance characteristics.
- Ensure compliance with relevant packaging material testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidance.
- Lead or support activities related to customer, supply, and distribution requirements in packaging and pharma processes.
- Produce technical reports and documentation to support new product registrations (FDA/EMA).
- Work in cross-functional teams to troubleshoot and perform root cause analysis.
- Travel to Toronto (2-3 times per year) to support process needs, estimated 1 week per trip.
- Education: Bachelor's Degree (or higher) in Process/Package Engineering. Candidates with MS or Ph.D. degrees will also be considered.
- Experience: Minimum 7 years in a similar role within the biotech or pharmaceutical industry, specifically in liquid formulations and packaging.
- Regulatory Knowledge: In-depth knowledge of FDA and EMA regulations, including documentation requirements.
- Technical Skills: Strong technical writing experience, with the ability to write reports, protocols, and technical documentation.
- Packaging Expertise: Knowledge of packaging systems and standards (USP, ASTM, ISTA, IATA, CFR, FDA Guidance).
- Project Management: Strong project management experience, with a proven ability to manage technical activities across multiple teams.
- Soft Skills: Excellent written and verbal communication skills in English. Ability to work in cross-functional teams, analyze data, and provide troubleshooting and root cause analysis.
- Travel: Must be willing to travel to Toronto and other locations as needed.
- Experience in equipment startup, qualification, and validation (Process and Packaging).
- Familiarity with packaging material systems and regulatory testing requirements.
- Biotech and Pharma experience, particularly in packaging and process support.
- Reimbursement will be provided for travel, and some overtime may be required during travel periods.
