Process Simulation Technical Engineer
11 month contract
On site Carlow
AS22206


We are currently looking for an experienced Process Simulation Technical Engineer for a rapidly expanding biotechnology company in Carlow.

In this role you will be responsible for providing process, technical, and validation support to operations for Process Simulation development and execution. You will be accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations.

The ideal candidate will have 3-5 years experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.

Responsibilities

Serve as technical support for manufacturing and new product introduction.

• Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support.
• Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations.
• Design/Author/Review/Approve/Execute process simulation qualification/validation documentation and studies in line with the standard approval process
• Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis
• Support continuous improvement through Lean Six Sigma methodologies.
• Leading and active participation in projects, system failure investigations and investigation reports,
• Execution/development of change controls to support the Process Simulation process
• Contribution to Kaizen events as appropriate.
• Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;
• Implement subsequent corrective action through the change management system.
• Serve as technical engineering representative for internal technical group discussions and represent technical operations Carlow at global technical forums in relation to process simulations.
• Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
• Drive compliance of 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
• May be required to perform other duties as assigned.

• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline
• 3 - 5 year’s operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
• 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
• Lean Six Sigma Methodology experience desired