Process Engineer

4 weeks ago

The Municipal District of Carlow, Ireland KPC International Full time

KPC International - Excellence from Concept to Completion

Process Engineer II - Carlow

KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world 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 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 based in Carlow and is 12 month's contract. This is an onsite role.

Main Duties Will Include

  • 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
  • Technical input into quality notification by authoring/reviewing/approving investigations
  • Execution of 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, 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 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
  • 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
  • Min 3 years experience ideally in manufacturing, GMP Setting
  • Demonstratable experience of leading technical related projects
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity
  • 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
  • Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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.

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