Job Description
The Process Engineer Head of PAT Implementations will be part of a cross functional team of product managers, project managers and software engineers. The Process Engineer Head of PAT Implementations will have a thorough understanding of pharmaceutical solid oral dose manufacturing with particular insight into unit operations such as granulation and coating. The Process Engineer Head of PAT Implementations will work closely with technology and pharmaceutical partners to develop and support methods to qualify the use of technology to measure Critical Process Parameters (CPP) for the purposes of tracking and controlling a process. They will also closely support sales and marketing in progressing sales.
Key Experience:
Understanding of customer application priorities & challenges.
Experienced in powder process development, scale up, validation, technical transfer and commercial manufacture.
Strong background in multivariate data analysis, chemo metrics and spectroscopy and a broad knowledge in process analytical methods such as particle sizing, image analysis or NIR.
Experience in developing and implementing IPC Strategy for approved pharma process
Experienced in DoE granulation or coating including contribution to a common technical document preparation for CMC.
Good understanding of USP methodologies, ICH Guidelines, cGMP and FDA/EMA regulations as they pertain to solid dose manufacture.
Experience with PAT instrument qualification, validation, and calibration including IQ/OQ/PQ and 21-CFR Part 11 compliance.
Knowledge of MES/PAT ICT integration
Team player, strong enough to challenge product package to deliver the technical performance and achieve requirements for compliance
Extensive international travel multicultural experience
Skills & Qualifications:
Minimum requirement of a degree in engineering or science related discipline.
Strong oral and written communication skills to capture key information and determine business needs; - expected to interact with various groups such as Process Engineers and Formulation Development for meetings, presentations at levels up to VP/director level
High level of independence and initiative while working effectively as part of a team and high level of accountability for assigned responsibilities
Effective interpersonal skills including the ability to collaborate and influence at various levels of the organisation.
CV and cover letter to Laurentina Kennedy at The RFT Group laurentina@rftgroup.ie 01 2302400 / www.rftgroup.ie
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RFT Group: Pharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the pharmaceutical, medical device, supply chain logistics and human resources.