Shift Process Engineer - Contract - Life Sciences
We are seeking a highly skilled Shift Process Engineer to join our team in Carlow, Ireland. This is an exciting opportunity to work on critical investment projects and be involved in the development and production of veterinary vaccines.
Responsibilities:
* Design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
* Provide technical input into quality notifications by authoring, reviewing, and approving process simulation-related investigations.
* Design, author, review, approve, and execute commercial and 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.
* Lead and actively participate in projects, system failure investigations, and investigation reports.
* Execute/develop change controls to support the Process Simulation process.
* Contribute 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 whys, 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 validation.
* Sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications required.
* Lean Six Sigma Methodology experience desired.
* Experience in an 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 a highly regulated controlled environment.