SHIFT PROCESS ENGINEER

Shift Process Engineer - Contract - Life Sciences - Carlow, Ireland  Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than people.
They are looking to add to their team and require a Shift Process Engineer.
This a fantastic opportunity to be involved with the critical investment projects both on-site and remotely.
Responsibilities.
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.
.
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 Merck 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.
Requirements.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Report, standards, policy writing skills required Equipment and process validation7 Sterile filling processes and equipment Proficiency in Microsoft Office and job related computer applications required Lean Six Sigma Methodology experience desired 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 If this interests you, please apply today!  #LI-CH3