Process Engineer
Carlow
11 months
Hybrid with occasional shift work
AMC21925



We are currently looking for a Process Engineer to join the Process Engineering Group on site for a global biopharmaceutical manufacturer based in Carlow.

You 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.

You will 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.

Our 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.


Responsibilitie

• Design/Author/Review/Approve/Execute qualification/validation documentation, process development studies and change control in line with the standard approval process.
• Contribute 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.

• Bachelors degree
• 3 years experience in GMP enviornment including Process Engineering experience
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment (desirable)
• Equipment and process validation
• Sterile filling processes and equipment
• Demonstratable experience of leading technical related projects