Head of Process Engineering Service
|Job Title:||Head of Process Engineering Service|
|Contact Name:||Laurentina Kennedy|
|Job Published:||about 1 year ago|
You will lead the development of the international pharma support services business in the areas of technology transfer, scale up and process troubleshooting.
The Process Engineer will help drive new business by supporting customers in the application of the PAT technology to track, support and troubleshoot processes. You will also and drive the publication of data that qualifies the use of the technology and streamline for customers the means by which they can effectively implement the technology.
The Process Engineer will work closely with the technology and pharmaceutical partners to develop and support methods to qualify the use of the technology to measure Critical Process Parameters (CPP) for the purposes of tracking and controlling a process. You will also closely support sales and marketing in progressing sales.
Thorough understanding of pharmaceutical solid oral dose manufacturing with particular insight into unit operations such as fluid bed granulation and coating.
Strong understanding of validation of solid dose pharma facilities, equipment and process
Thorough knowledge of GMP, quality and regulatory industry trends, policies and guidelines.
Experienced in powder process development, scale up, validation, technical transfer and commercial manufacture.
Leadership experience leading teams, projects, programs or directing the allocation of resources.
Experience in developing and implementing IPC Strategy for approved pharma process
Experience in multivariate data analysis and modelling of process data.
Knowledge of QBD and 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.
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 and multicultural experience
Skills & Qualifications:
Minimum requirement of a degree in engineering or science related discipline.
High level of independence and initiative while working effectively as part of a team and high level of accountability for assigned responsibilities
Proven skills in building and maintaining productive relationships with organisational partners.
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
Effective interpersonal skills including the ability to collaborate and influence at various levels of the organisation.
For further information on this Head of Process Engineer position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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