Process Engineer

PE Global is currently recruiting for a Process Engineer for a leading multi-national Biotech client based in Carlow.

This is an initial 11-month contract position working on a 4-cycle shift.

ROLE:

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 commercial & 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 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 at site.
May be required to perform other duties as assigned.

REQUIREMENTS:

Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline
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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Seán on +353 21 4297900 or alternatively send an up to date CV to sean.molloy@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***