Job Description
Our client, an innovative pharmaceutical development and manufacturing company, now seek a Lead Process Engineer. This hire will develop and communicate objectives for the team, linked to site strategy and ongoing business demands. Additionally, this hire is required to lead Product and Process Engineering projects, designed to deliver: robust, predictable and optimised manufacturing processes mainly for commercial manufacture.
The successful hire will also work on assigned projects to scale-up/transfer of new products and processing technologies from development stage through to routine full-scale manufacture, ensuring a cost effective, compliant and robust process is achieved. This role will work with both the internal cross-functional teams (including the site leadership team) and external groups (Suppliers, CDOs, CMOs, etc).
The ideal candidate will have strong Process Engineering experience in Solid Oral Dose forms, with strong leadership and communication expertise.
Responsibilities for Lead Process Engineer:
Project management to meet budget allocation, either directly as a project leader or as a project team member.
Identify, develop and implement opportunities for the application of new technologies/techniques in existing processes.
Leading risk based decision making and making risk based judgements based on the interpretation of complete and in process data sets.
Overall responsibility for multiple processes, accountable for the initiation, design, resourcing and budget of complex processing improvements.
Provide technical expertise to teams to achieve product scale-up or tech transfer.
Utilise lean tools and statistics/DOE packages to deliver world class process robustness on all commercial products.
Lead development of documentation to support change (SOP’s, manufacturing records, URS) and report writing (PPI’s, corrective actions, process improvement and robustness).
Close liaison with maintenance department to facilitate implementation of works orders and pre-determined schedules (calibrations, PM programmes).
Ensuring that all cGMP requirements are achieved in terms of use, training, data collection, process controls and cleaning.
Ensuring plant production targets are met on weekly basis.
Training of personnel on any plant modifications or new equipment installations.
Requirements for Lead Process Engineer:
Bachelor’s Degree in Science or Engineering.
6+ year’s industrial experience in similar role, in FDA regulated GMP environment.
Proven experience of new technologies in the pharmaceutical manufacturing environment.
Process Analytical Technology or Historian experience is preferred.
Track record in managing projects from start to finish.
Responds positively to changing circumstances and priorities.
Strong communication and collaboration skills.
For further details, contact Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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