Job Purpose: 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.
Responsibilities of the role include:
- Provide engineering support to R&D Sterile
Fill Finish development teams and projects
- Develop and support new manufacturing processes and technologies
- Understand equipment operation in detail
- 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.
Health, Safety and the Environment
- 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
The ideal candidate for the role will:
- Be qualified to a minimum of Degree level in engineering or related discipline
- Have minimum 1 year of Process Engineering experience within a relevant Pharma environment (preferably within a sterile manufacturing environment)