Process Engineer
ICDS Recruitment
Waterford
Process Engineer (Sterile)- Waterford. Key Purpose. The ideal candidate will be required 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. The role reports to the Lead Process Engineer. Key Responsibilities. • 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. • 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. Minimum Qualifications & Experience. Qualified to a minimum of Degree level in engineering or related discipline. Minimum 1 year of Process Engineering experience within a relevant Pharma environment. Information Skills and Behavioural Competencies. • cGMP compliance. • Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem solving techniques. • Ability to understand engineering processes through a logical, data driven, hands on approach. • Use of FMEA, FMECA and Risk assessment techniques. • Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective. • Strong report writing skills. This job originally appeared on RecruitIreland.com.
1835 days ago