Process Engineer

Desired Skills: QA,GMP,validation,NPI,DeltaV,Process engineer,Tech Transfer

PE Global is currently recruiting for a Process Engineer on behalf of our Biotech client based in Carlow. 11-month initial contract.

Hybrid role (once successful completion of training, occasional shift support as required based on program needs)

The Process Engineer will join the Process Engineering Group on site and report to the Technical Engineering Manager.

The new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience.

Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role 

The Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. 

Role Functions

• Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process 
• Design/Author/Review/Approve/Execute Execution/development of change controls 
• Contribution to Kaizen events as appropriate 
• Technical input into quality notification by authoring/reviewing/approving investigations 
• Execution of equipment/qualification validation programs; including re-qualification and re-validation 
• Support continuous improvement through Lean Six Sigma methodologies 
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues 
• Serve as technical engineering representative for internal technical group discussions and represent technical Operations Carlow at global technical forums 
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance 
• Work collaboratively to drive a safe and compliant culture in Carlow 
• May be required to perform other duties as assigned 

Qualifications & Education

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline 
• Min 3 years experience ideally in manufacturing, preferably GMP Setting 
• Demonstratable experience of leading technical related projects 
• Evidence of continuous professional development is desirable 
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity 
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices 
• Report, standards, policy writing skills required 
• Equipment and process validation 
• Sterile filling processes and equipment 
• Proficiency in Microsoft Office and job-related computer applications required 
• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner 
• Hybrid role once successful completion of training, occasional shift support as required based on program needs

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up to date CV  to chloe.slingsby@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***