Process Engineer

3 weeks ago


Dublin, Dublin City, Ireland Asset Recruitment Full time

ref. 01112

Process Engineer – Fill Finish

The External Manufacturing (ExM) Technical Operation organization is looking for a results-driven candidate for a Technical Transfer – Fill Finish position. ExM Technical Operation is accountable for technology transfers and commercial production of sterile drug product at our External Partners (EPs).

This is an opportunity for a motivated person to participate in all these areas, including providing manufacturing process support to solve potential commercial production issues, supporting execution of technology transfers and to provide support for process and capacity optimization.

Responsibilities:

• Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.

• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.

• Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.

• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.

• Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.

• Responsible for participation in creating, sharing, and adopting best practices and business process strategies.

Requirements:

• Travel will be a requirement at approximately 25%

Qualifications:

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Experience and Skills:

• Fill finish product tech transfer experience

• 4 years+ post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance

Preferred Experience and Skills:

• Experience in Fill Finish activities – Vial / Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.

• Experience in deviation management and/or change control and/or equipment support, and/or project management.

• Ability to independently Manage projects/work to schedule/deadlines

• Statistics experience (including Proactive Process Analysis and Continuous Process Verification)

#J-18808-Ljbffr
  • Process Engineer

    6 days ago


    Dublin, Dublin City, Ireland Arcon Recruitment Services Full time

    Process engineer required for client in Ballina Co.Mayo Apply a proactive and methodical approach to troubleshooting daily shift operation issues and continuous improvement with cross functional teams, comprised of operations shift managers, technicians, engineers, quality, and safety. Perform detailed, technical breakdown analysis of improvements (losses...

  • Process Engineer

    2 hours ago


    Dublin, Dublin City, Ireland Asset Recruitment Full time

    ref 01109 Process Engineer – Upstream/Downstream Process Role Provide technical expertise in Upstream/Downstream processing to offer support to the commercial manufacturing of therapeutic proteins in a mammalian cell culture facility. The successful candidate will be responsible for ensuring that manufacturing processes are validated and maintained...

  • Process Engineer

    3 weeks ago


    Dublin, Dublin City, Ireland Orion Group Full time

    Orion Group Life Sciences are currently recruiting a Process Engineer (Senior) - Hybrid on behalf of our Multinational Biotechnology Client based in South Dublin on initial 12-Month contract with huge potential to extend.Onsite expectations: Onsite expectations are 3+ days per week. We can provide flexibility in which days the individual is onsite - it'll be...


  • Dublin, Dublin City, Ireland AtkinsRéalis Full time

    AtkinsRéalis Ireland is a member of SNC-Lavalin, one of the world's leading providers of engineering professional consulting and support services with offices across Ireland. We are seeking for a Senior Process Engineer , with 10+ years' experience in the water/wastewater sector to join the Infrastructure Division. The candidate should have a variety of...


  • Dublin, Dublin City, Ireland Amgen Full time

    Job Posting Title Sr Engineer - Drug Process DevelopmentCareer Category Process DevelopmentEmployee Subgroup TBCCountry (State/Region) IrelandLocation (City) Ireland - ADLAmgen Job DescriptionThe Sr Engineer provides process development technical support to large molecule and small molecule drug product manufacturing at ADL as well as part of the global...


  • Dublin, Dublin City, Ireland Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • Process Scientist

    4 days ago


    Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer are currently recruiting for a Process Scientist - Small Scale FlexBackground:This is an ideal development opportunity to join a dynamic team who provide process science support/ new product tech transfer into the drug substance facility at Pfizer Grange Castle. The jobholder works with the Technical Services teams...

  • Bio Process Associate

    3 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    An exciting opportunity to join a large pharmaceutical company.You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance at the manufacturing facility.You will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks...


  • Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Global are currently recruiting for aProcess Development ScientistJob Title: Purification Process Development Scientist (Level 2)Department: Manufacturing Science and Technology - Process DevelopmentPosition Reports to: Principal Scientist (Level 4 / Manager), Process DevelopmentWhy Patients Need YouPfizer's purpose...


  • Dublin, Dublin City, Ireland Amgen Inc. (IR) Full time

    Manufacturing Process Technnician - Inspeciton - FTC page is loaded Manufacturing Process Technnician - Inspeciton - FTC Apply remote type On Site locations Ireland - Dublin time type Full time posted on Posted Yesterday job requisition id R Career Category Manufacturing Job Description Job Description Job Description Summary The Manufacturing...


  • Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for a Senior Scientist: Process Modelling and Hybrid Modelling The Manufacturing Intelligence (MI) team within Pfizer's Global Technology & Engineering (GT&E) is responsible for driving the development and implementation of advanced analytics including AI/ML, soft sensor,...


  • Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for aSenior Scientist: Process Modelling and Hybrid Modelling The Manufacturing Intelligence (MI) team within Pfizer's Global Technology & Engineering (GT&E) is responsible for driving the development and implementation of advanced analytics including AI/ML, soft sensor,...


  • Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for aSenior Scientist: Process Modelling and Interpretable Machine Learning The Manufacturing Intelligence (MI) team within Pfizer's Global Technology & Engineering (GT&E) is responsible for driving the development and implementation of advanced analytics including AI/ML, soft...


  • Dublin, Dublin City, Ireland Cpl Full time

    Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for a Senior Scientist: Process Modelling and Interpretable Machine Learning The Manufacturing Intelligence (MI) team within Pfizer's Global Technology & Engineering (GT&E) is responsible for driving the development and implementation of advanced analytics including AI/ML, soft...


  • Dublin, Dublin City, Ireland GrabJobs Full time

    Cpl in partnership with our client Pfizer Grange Castle are currently recruiting for a Senior Scientist: Process Modelling and Interpretable Machine Learning The Manufacturing Intelligence (MI) team within Pfizer's Global Technology & Engineering (GT&E) is responsible for driving the development and implementation of advanced analytics including AI/ML, soft...


  • Dublin, Dublin City, Ireland CPL Healthcare Full time

    Our client is seeking a dynamic Manufacturing Engineer with expertise in equipment introductions and process improvements. If you're passionate about optimising manufacturing processes, we want to hear from you This is a 12-month contract. Responsibilities: · Design manufacturing processes, procedures and production layouts for assemblies, equipment...

  • Production Engineer

    2 weeks ago


    Dublin, Dublin City, Ireland GrabJobs Full time

    Job summaryProduction Engineer position Applies Lean manufacturing techniques Identifies and supports improvement efforts Job seniority: mid-to-senior level Responsibilities Applies Lean manufacturing techniques to continuously improve cycle times and process flows Identifies and supports the execution of improvement efforts to reduce waste in all...

  • Project Engineer

    2 weeks ago


    Dublin, Dublin City, Ireland timesjobs Full time

    POSITION OVERVIEWManage and undertake the required engineering activities within the following areas:Subcontract management, system definition, requirements capture, compliance management, integration of designs, construction integration, CDM (Construction, Design and Management Regulations), safety assurance activities, project programme, system validation,...

  • Mechanical Engineer

    3 weeks ago


    Dublin, Dublin City, Ireland EXEC Search Full time

    Role: Mechanical Engineer As a Mechanical Engineer, you will be responsible for designing, analyzing, and improving various mechanical systems and components. You will work closely with our client's engineering team to ensure that the products meet the highest quality and safety standards. Responsibilities:Design and develop mechanical systems and components...

  • Mechanical Engineer

    3 weeks ago


    Dublin, Dublin City, Ireland Cpl Full time

    JO Our client, based in Swords, requires a hands on Mechanical Equipment Engineer to join their team. This is an exciting opportunity to grow your career with a global company, specializing in precision engineering.Role· Support manufacturing processes and provide process improvements to existing products· To define and validate manufacturing process for...