Senior Process Engineer-Particle Engineering
Devens, MA, USA | Johnson Matthey
Job Description:61 people have viewed this job
Role of this position is to provide technical and team leadership for development of pre-formulation particle engineering steps for Active Pharmaceutical Ingredients (APIs).Processes under development will include operations such as spray drying, jet milling, impact milling, and wet milling.The engineer will plan and lead the development and implementation of particle engineering solutions for development and clinical scale-up batches of new drug substances, designing processes to deliver specified quantity, quality, and budget.Also responsible for contributions to continuous improvement, customer satisfaction, operational safety and efficiency of the function.
Works with Department and Assistant Director Process Engineering to build and enhance particle size capabilities for API manufacturing at JM Devens as well as within the wider division.
Hands-on execution of milling and particle size development experiments, carrying out milling development as well as GMP milling operations so that definitive conclusions are made, and deliverables are met. Work will involve both hands-on development as well as oversite and collaborative work with chemists, plant and quality personnel.
Performs milling and particle engineering process development in accordance with Johnson Matthey policies and practices with respect to GMP, environmental, health, and safety (EH&S) and other related regulatory requirements.
Maintains up to date awareness of the latest developments in particle engineering and allied areas through literature review, conferences, vendor discussions and related activities.
Design and carry out complex research projects so that definitive scientific conclusions are reached. Seek out and test valid explanations for all results.
Responsible for authoring relevant sections of regulatory documents, validation plans, reports and peer-reviewed manuscripts.
Builds capabilities in and integration of PAT, process modelling, scale up calculations, Quality by Design (QbD) and other related activities.
Responsible for contributions to continuous improvement in customer satisfaction, regulatory compliance, and operational safety and efficiency of the function.
Ensures projects are managed and completed on target with quantity, quality, time, and within budget.
Drives innovation, identifying and evaluating new technology opportunities.
Are you the ideal candidate?
Minimum of B.S. in Chemical Engineering or related scientific discipline; M.S. or Ph.D. a plus.
5+ years of relevant industry experience.
Knowledge of chemical engineering principles and experience in process scale up.
Experience managing development projects or capital projects with various priorities, deadlines, user requirements and technical challenges.
Basic knowledge of analytical techniques.
Ability to define problems, collect data, recognize patterns, and draw valid conclusions and deal with both abstract and concrete variables
Experience in data processing and manipulation.
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