Process Engineer

1 day ago

The Municipal District of Carlow, Ireland Tandem Project Management Ltd. Full time
ERF CertRP | Talent Solutions Specialist | Sourcing & Developing Life Sciences Talent

Summary:

A Process Engineer is required to join the Process Engineering Group on-site at a biopharmaceutical company in Carlow. The successful candidate will provide technical support for new product introductions (NPI) and commercial manufacturing.

Responsibilities
  • 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.
  • Contribution to Kaizen events as appropriate.
  • 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 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, participating in audits and inspections and proactively highlighting any issues around compliance.
Qualifications & Experience
  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Min 3 years' experience, ideally in manufacturing, preferably GMP setting.
  • Demonstrable experience in leading technical-related projects.
  • Evidence of continuous professional development is desirable.
  • 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, and policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.
  • Hybrid role, once successful completion of training. Occasional shift support as required based on program needs.
Seniority level
  • Associate
Employment type
  • Contract
Industries
  • Pharmaceutical Manufacturing

#J-18808-Ljbffr

  • Process Engineer

    4 days ago

    The Municipal District of Carlow, Ireland PE Global Full time

    Direct message the job poster from PE GlobalOverviewPE Global is currently recruiting for a Process Engineer on behalf of our Biotech client based in Carlow.11-month initial contract.Hybrid role (once successful completion of training, occasional shift support as required based on program needs).The Process Engineer will join the Process Engineering Group on...

  • Process Engineer

    3 days ago

    The Municipal District of Carlow, Ireland PSC Biotech® Corporation Full time

    OverviewNew exciting opportunity now exists on our Carlow Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager. Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single...

  • Process Engineer, Packaging Processes

    3 weeks ago

    The Municipal District of Ashbourne, Ireland PCI Pharma Services Full time

    Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.We are now looking for a Process Engineer, Packaging...

  • Business Process Analyst

    1 day ago

    The Municipal District of Carlow, Ireland Jones Engineering Full time

    OverviewPosition: Business Process AnalystLocation: CarlowCompany DescriptionWe are a leading engineering services company with a proven track record of high quality, customer focused project delivery for over 130 years. Our core divisions include Mechanical Engineering, Electrical Engineering, Sprinkler and Fire Protection. Some of the other services we...

  • Process Engineer

    5 days ago

    Carlow, Ireland Claran Consultants Ltd Full time

    New exciting opportunity now exists on our Carlow Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function...

  • Process Engineer

    4 days ago

    Carlow, Ireland Claran Consultants Ltd Full time

    New exciting opportunity now exists on our Carlow Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function...

  • Process Engineer

    5 days ago

    Carlow, Ireland Quanta part of QCS Staffing Full time

    Process Engineer - Contract - Ireland  With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster. This is a fantastic opportunity to work on a state-of-the art fill-finish...

  • Process Engineer

    1 week ago

    Carlow, Ireland Psc Biotech Ltd Full time

    Job DescriptionAbout PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and...

  • Process Engineer

    2 days ago

    Carlow, Ireland Quanta part of QCS Staffing Full time

    Process Engineer (Aseptic Lead) - Carlow, Ireland - 11-Month Contract  With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Process Engineer to join their team to support multiple capital projects taking place onsite in Leinster. This is a fantastic opportunity to work...

  • Graduate Business Process Analyst- Carlow

    1 day ago

    The Municipal District of Carlow, Ireland Jones Engineering Full time

    Company DescriptionWe are a leading engineering services company with a proven track record of high quality, customer focused project delivery for over 130 years. Our core divisions include Mechanical Engineering, Electrical Engineering, Sprinkler and Fire Protection. Some of the other services we provide include Waste to Energy (BioEnergy), Specialist Lift,...