Shift Process Engineer

Shift Process Engineer
11 month contract
On site - Carlow
AS21873


We are looking for several Shift Process Engineers for an expanding biotechnology client based in Carlow.
In this role you will be responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations.


This is the perfect role for a Graduate with 1-2 years of GMP industry experience in aseptic manufacturing.

In this role, you will:

• Design, author, review, approve, and executeprocess simulation studies to support both new product launches and ongoing manufacturing activities.
• Providetechnical inputby authoring, reviewing, or approving process simulation-related investigations as part of quality notifications.
• Oversee thequalification and validationof commercial and process simulation studies, ensuring alignment with standard approval processes.
• Analyze data to makeinformed decisions and recommendationsbased on findings.
• Supportcontinuous improvement initiativesthrough Lean Six Sigma methodologies.
• Lead and participate in projects, system failure investigations, and the preparation of investigation reports.
• Develop and executechange controlsto enhance the process simulation workflow.
• Contribute toKaizen eventsand other process improvement initiatives.
• Conductroot cause analysisfor system failures or performance issues, utilizing tools such as FMEA, Fishbone diagrams, and 5 Whys.
• Implement corrective actions via thechange management system.
• Serve as thetechnical representativein internal and global discussions related to process simulations.
• Collaborate with cross-functional teams and liaise with external vendors or global teams as needed.
• Ensure adherence toPolicies, Procedures, and Guidelines, as well as regulatory and cGMP (current Good Manufacturing Practices) requirements.
• Maintain accountability for compliance through risk assessments, corrective actions, audit participation, and proactive issue identification.
• Promote asafe and compliant work culturewithin the facility.

• Experience in a Aseptic sterile manufacturing environment preferred
• Demonstrated ability to coach and lead change
• Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment
• Bachelors degree in science, engineering or other technical disicpine