Process Engineer - Sterile
Posted on Apr 4, 2019 by Thornshaw Recruitment
To provide engineering support to the R&D Sterile Fill Finish function, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of new and existing products.
Provide engineering support to R&D Sterile Fill Finish development teams, projects and new manufacturing processes and technologies.
Understand equipment operation in detail and define and review equipment specification and associated test documentation.
Support project delivery through FAT, SAT and IOQ involvement as needed.
Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing).
Identify means to improve processes, increase efficiencies and reduce costs.
Strong focus on disciplined root cause analysis.
Liaise with vendors on disposable technology and integration into the process.
Development of process cleaning and sterilization cycles.
Development of critical process parameters for the process and development of process capability and deviation monitoring.
Monitor process risk and ensure mitigations are in place as required.
Benchmark other industries and organizations to ensure best practice is in use.
Be active in the network, attending conferences/training seminars as needed.
Comply at all times with the Health, Safety and Environmental policy and associated procedures.
Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP's and regulatory guidelines.
Take ownership for quality compliance in all activities under the responsibility of the role
Qualified to a minimum of Degree level in engineering or related discipline.
Minimum 1 year of Process Engineering experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
If you are interested in applying for this role please call Zoe on 1 or email
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group.