Process Engineer

3 weeks ago

Dublin, Dublin City, Ireland KPC International Full time
Overview

KPC International - Excellence from Concept to Completion

Process Engineer II - Carlow

KPC International began operations in 2001. Our team of Engineers and Scientists has helped our clients achieve project success worldwide within the pharmaceutical and biopharmaceutical space. We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.

We are looking for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager. You will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams, including liaising with vendors or above-site groups. The project is based in Carlow and is a 12 month contract. This is an onsite role.

Main Duties
  • Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process
  • Design/Author/Review/Approve/Execute execution/development of change controls
  • Provide technical input into quality notifications by authoring/reviewing/approving investigations
  • Execute equipment/qualification validation programs, including re-qualification and re-validation
  • Support continuous improvement through Lean Six Sigma methodologies
  • Perform root cause analysis of system failures or substandard performance, using standard tools and methods, to resolve machine and system issues
  • Serve as technical engineering representative for internal technical group discussions and represent Technical Operations Carlow at global technical forums
  • Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute cGMP in day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance; document completion, risk assessments, closing out corrective actions, participate in audits and inspections, and proactively highlighting any issues around compliance
  • May be required to perform other duties as assigned
Essential Skills / Qualifications
  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Minimum 3 years experience, ideally in manufacturing, GMP setting
  • Demonstrated experience of leading technically related projects
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial but not required
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Proficiency in Microsoft Office and job-related computer applications
  • Excellent communication, presentation and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner
Company

KPC - International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others. KPC – International is an Equal Opportunity Employer.

Seniority level
  • Mid-Senior level
Employment type
  • Contract
Job function
  • Manufacturing and Engineering
  • Industries: Pharmaceutical Manufacturing

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