What you need to know
 

We are currently seeking a Process Engineer for our biopharmaceutical client, based in Waterford.

This is an excellent opportunity to join a dynamic team during an exciting growth phase.

This is a permanent role with an excellent salary and benefits package on offer.

Your new job

Key duties & responsibilities:

• Provide process engineering support to Sterile Fill Finish product 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.

What are we looking for?

• Hons Degree in engineering or related discipline 

• At least 8 years Process Engineering / Technical Services experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment) 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

Please apply using a CV in Microsoft Word format, thank you.

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent.

Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.