Process Engineer

Process Engineer
Experienced Process Engineer required for multinational pharmaceutical startup in Waterford City.
The purpose of the role is to provide process engineering support to Sterile Fill Finish Drug Product, in the design, commissioning and qualification of equipment and processes to facilitate the manufacture of development, clinical and commercial existing products.
  • Provide process engineering support to Sterile Fill Finish product teams and projects
  • Develop and support new manufacturing processes and technologies
  • Understand equipment operation in detail
  • Define and review equipment specification and associated test documentation.
  • Support project delivery through FAT, SAT and IOQ involvement as needed
  • Troubleshoot equipment issues with particular emphasis on process cycles (e.g. cleaning, sterilizing)
  • Identify means to improve processes, increase efficiencies and reduce costs
  • Strong focus on disciplined root cause analysis
  • Liaise with vendors on disposable technology and integration into the process
  • Development of process cleaning and sterilization cycles
  • Development of critical process parameters for the process and development of process capability and deviation monitoring
  • Monitor process risk and ensure mitigations are in place as required
  • Benchmark other industries and organizations to ensure best practice is in use.
  • Be active in the network, attending conferences/training seminars as needed
Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
Quality Compliance
  • Ensure all work carried out, complies with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities under the responsibility of the role
Qualifications and Skills Required:
  • Qualified to a minimum of Degree level in engineering or related discipline
  • Minimum 8 years of Process Engineering / Technical Services experience within a relevant Pharma. environment (preferably within a sterile manufacturing environment)
Skills and Behavioural Competencies Skills
  • cGMP compliance
  • Capable of developing and implementing solutions to complex problems within a team dynamic using proven problem solving techniques
  • Ability to understand engineering processes through a logical, data driven, hands on approach
  • Use of FMEA, FMECA and Risk assessment techniques
  • Can interact with audits (internal and external) providing technical assurance from a quality and safety perspective
  • Strong report writing skills
  • Behaviours
  • Focus on people and process.
  • Motivating others positively
  • Ability to work independently and in teams
  • Natural influencer
  • Be driven by task / project and will show flexibility to ensure results are achieved.
  • Self-starter and accustomed to setting personal goals
  • Reports to: Lead Process Engineer