Process SME – API

4 weeks ago


Dublin, Dublin City, Ireland QCS Staffing Ltd Full time

1 week ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Process SME – API - Ireland, Dublin - 12 Month Contract

How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you

Our client is currently seeking the skills of Process SME to join their team.Our client develops and delivers life changing medicines to millions of people globally and as part of their growth. With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

  • Understand business objectives, project scope, schedule, and critical success factors
  • Understand and engage project stakeholders relevant to SME role
  • Participate in the APICOM capital project team through all phases of project
  • Understand your project remit in terms of scope of work and interfaces with other SME's scope of works.
  • Ensure requirements are appropriately documented and agreed with project stakeholders
  • All GMP URSs to be documented and agreed with project stakeholders in basic design
  • Work collaboratively with project stakeholders, including collaboration between other packages and disciplines
  • Ensure requirements are understood and included in the scope of works of designer
  • Proactive engagement with designer to ensure design is being developed in line with requirements
  • Produce agreed project deliverables in accordance with project schedule deadlines
  • Support work package owners in understanding requirements and design basis and in planning and delivery of work packages
  • Support procurement activities, as required
  • Consulted on work package breakdown and scope of works
  • Participation in project meetings, design meetings, SME meetings, and project tier meetings, as agreed with PTM
  • Raise issues and escalate through agreed project processes
  • Input into project risk register and project/work package cost/schedule reviews
  • Responsible for design assurance reviews for assigned technical packages
  • Consulted on C&Q plan
  • Input into SHE risk assessments and Engineering Compliance tracker
  • Reporting of progress, issues, and escalations to ETS tier process
  • Review design deliverables to validate that they meet requirements, Including Design Qualification for GMP packages
  • Support PTM in preparation for Engineering Council
  • Prepare requirements for Detailed Desig
  • Participate in project learning reviews

Desirable Experience:
  • Experience with API (Small molecule) & Process design
  • Strong stakeholder management.
  • Assess equipment needs and support the generation of equipment URS and specifications for design or purchase
  • Experience with GMP URSs, which will be agreed with project stakeholders in basic design
  • Ensure requirements are understood and included in the scope of works of designer
  • Consult in the C&Q plan

If this role is of interest to you, please apply nowSeniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeContract
Job function
  • Job functionManagement and Manufacturing
  • IndustriesStaffing and Recruiting

Referrals increase your chances of interviewing at QCS Staffing by 2x

Sign in to set job alerts for "Process Specialist" roles.

Dunboyne, County Meath, Ireland 1 week ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 3 weeks ago

Dublin, County Dublin, Ireland 2 weeks ago

Clondalkin, South Dublin, Ireland 1 week ago

Sustainability Process Specialist (Ireland)

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 5 days ago

Stamullen, County Meath, Ireland 2 days ago

Dublin, County Dublin, Ireland 6 days ago

Process Engineer – Customer Support (SaaS) - 10514

Dublin, County Dublin, Ireland 4 days ago

Dublin, County Dublin, Ireland 2 weeks ago

Food Safety and Quality Technical Specialist

Dublin, County Dublin, Ireland 1 week ago

Process Manager (Acquisitions & Development)

Dublin, County Dublin, Ireland 1 week ago

Senior Operations Specialist - (Day shift Monday to Friday)

Dublin, County Dublin, Ireland 2 weeks ago

Risk Operations and Process Management Specialist

Dublin, County Dublin, Ireland 2 weeks ago

Dunboyne, County Meath, Ireland 3 weeks ago

Process Engineer – Customer Support (SaaS) - 10514

Dublin, County Dublin, Ireland 4 days ago

Process Manager (Acquisitions & Development)

Dublin 8, County Dublin, Ireland 1 month ago

Dublin, County Dublin, Ireland 6 days ago

Process & Continuous Improvement Manager

Ashbourne, County Meath, Ireland 1 month ago

Dublin, County Dublin, Ireland 3 weeks ago

Dublin, County Dublin, Ireland 2 weeks ago

Quality Assurance Specialist - Standards, Monitoring and Compliance

Dublin, County Dublin, Ireland 5 hours ago

Senior Consultant - Oil & Gas, Refinery, Process Control Engineering (EU)

Dublin, County Dublin, Ireland 5 months ago

Dublin, County Dublin, Ireland 1 week ago

Dublin, County Dublin, Ireland 2 weeks ago

Dublin, County Dublin, Ireland 5 days ago

Dublin, County Dublin, Ireland 2 weeks ago

Product Reliability Analyst - Process Associate

Dublin, County Dublin, Ireland 1 week ago

Senior Process Safety Engineer - Pressure Relief Specialist

Dublin, County Dublin, Ireland 4 hours ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr
  • Process Design Sme

    4 weeks ago


    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    SummaryOur client is a global pharmaceutical company based in Dublin looking for a Process Design SME to lead the hydrogenation process design through to completion/FAT/installation/start-up and continuous processing train for installation/start-upResponsibilitiesUnderstand business objectives, project scope, schedule, and critical success factors.Understand...

  • Project SME

    4 weeks ago


    Dublin, Dublin City, Ireland Tandem Project Management Ltd. Full time

    1 day ago Be among the first 25 applicantsDirect message the job poster from Tandem Project Management Ltd.Associate Director, Talent Solutions at Tandem Project Management Ltd.Our client is a global pharmaceutical company based in Dublin looking for a Process Design SME to lead the hydrogenation process design through to completion/FAT/installation/start-up...

  • Senior API Specialist

    4 weeks ago


    Dublin, Dublin City, Ireland Irish Life Group Services Limited Full time

    Press Tab to Move to Skip to Content LinkSelect how often (in days) to receive an alert:Full Time Permanent positionHybrid role based in our City Centre officesWhat we offerWe have embraced a hybrid working model for most of our positions, which means that you can enjoy a balanced approach of working from home for part of the week and working from the office...

  • Automation SME

    4 weeks ago


    Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

    Automation SME / Lead - Ireland, Dublin - 12 Month ContractHow would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for youOur client is currently seeking the skills ofAutomation SME / Lead to join their team. Our client develops and delivers life changing medicines...

  • High Potency API

    4 weeks ago


    Dublin, Dublin City, Ireland CPL Full time

    Cpl in partnership with SK pharmteco in Swords are looking to hire a High Potency API (HPAPI) Specialist on a permanent contract.ABOUT US?SK in Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France, and Ireland. We are part of the wider SK Inc. with...

  • Senior API Specialist

    4 weeks ago


    Dublin, Dublin City, Ireland Irish Life Full time

    Join to apply for the Senior API Specialist (APIM) role at Irish Life1 day ago Be among the first 25 applicantsJoin to apply for the Senior API Specialist (APIM) role at Irish LifeHybrid role based in our City Centre officesWhat we offerWe have embraced a hybrid working model for most of our positions, which means that you can enjoy a balanced approach of...

  • API Support Engineer

    4 weeks ago


    Dublin, Dublin City, Ireland Principle HR Full time

    API Technical Support Engineer - Messaging Platforms - Global TechWhy this role?This is your chance to work on high-impact, low-volume Tier 3 support cases where your technical expertise really matters. You'll gain exposure to global-scale messaging technology, APIs, and enterprise integrations, while building strong cross-functional connections with...

  • Api Support Engineer

    3 weeks ago


    Dublin, Dublin City, Ireland Principle Hr Full time

    API Technical Support Engineer - Messaging Platforms - Global TechWhy this role?This is your chance to work on high-impact, low-volume Tier 3 support cases where your technical expertise really matters.You'll gain exposure to global-scale messaging technology, APIs, and enterprise integrations, while building strong cross-functional connections with...

  • API Support Engineer

    4 weeks ago


    Dublin, Dublin City, Ireland Principle HR Full time

    API Technical Support Engineer - Messaging Platforms - Global TechWhy this role?This is your chance to work on high-impact, low-volume Tier 3 support cases where your technical expertise really matters. You'll gain exposure to global-scale messaging technology, APIs, and enterprise integrations, while building strong cross-functional connections with...


  • Dublin, Dublin City, Ireland Smartedgesolutions Full time

    OverviewBusiness SME/ Business Consultant (Credit Risk) – Dublin, Ireland (Hybrid Working)Role posted by Smartedge Solutions. Direct message the job poster or email for contact details as provided.ResponsibilitiesWorking under Group Risk direction to decompose key risk indicators and reports to a data element level.Support the capture of high-level...