Browse by job sector

Process Lead

  1. Ireland, Dublin
Dublin
  1. Contract
Competitive
  1. Life Sciences
 37733I
Apply to this job Save job
Process Lead - Ireland, Dublin - 6 Month Contract (possible extension)

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 a Process Lead 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:
  • Set the technical direction and have overall accountability for the entire scope of work from initial concept through to successful operation
  • Act as Technical Decision maker for their area of scope
  • Review, accept and approve key technical documentation e.g. URSs, PIDs, FAT and SAT protocols
  • Work closely with the site receiving team. This is pivotal for success in preparing for the hand over from the technology viewpoint, ensuring the stabilisation of the introduction and capabilities are appropriate within the team to achieve a smooth transition and beneficial operation. 
  • Ensure User Requirement Specification (URSs) are produced and are complete (GMP, GEP, and Safety, Health & Environment requirements), technically accurate and appropriate for calibration and qualification execution.
  • UtiliSing LEAN and Change Management tools, provide strategic leadership to process improvement programmes sponsored by GERE or other senior stakeholders.
  • Ensure business continuity in the respective areas is maintained and areas of concern are flagged.
  • Support the planning and implementation of commissioning and qualification activities.
  • Lead process risk assessments in order to establish and deliver safe process operations and have complsance when manufacturing products to their quality standards.
  • Provide a leading input into process risk assessments (HAZOP, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
  • Be accountable for the technical input into the Design Review process and ensure that the project business objectives can be achieved.
  • Provide technical support to facility, equipment, system in the commissioning and qualification process.
  • Review and approve DQs, FATs and SATs for GMP critical systems as required.
  • Attend relevant pre-FATs SATs to assure completeness correctness and URS alignment can be delivered.
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 now!

#LI-SC1

Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Mechanical Utilities Engineer

Salary

Competitive

Location

Sligo

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Ireland

West

Description

Mechanical Utilities Engineer - Ireland, Sligo - 12 Month Contract  Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Mechanical Utilities

Reference

37736

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Calibration SME

Salary

Competitive

Location

Remote work

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Remote

Description

Calibration SME - Remote (Europe) - 4 Month Contract With more than 2,000 employees, more than 300 million units per year, and a lot of innovative medicines in the pipeline, no wonder our client

Reference

37748

Expiry Date

01/01/0001

Ben Pope

Author

Ben Pope
Ben Pope

Author

Ben Pope
Read more
Read more
EHS Advisor

Salary

Competitive

Location

Frankfurt ( Oder)

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Germany

Frankfurt

Description

EHS Advisor - Germany, Frankfurt - 18 Month Contract We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Frankfurt. Due to a large capital investment

Reference

37496

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more

Insights

QCS Staffing Validation Engineer Jobs: In-Demand Skills and Career Paths

Validation Engineer Jobs: In-Demand Skills and Career Paths
Read more

05/27/2025

QCS Staffing A Guide to Pharmacovigilance Careers

A Complete Guide to Pharmacovigilance Careers
Read more

05/15/2025

Living and working in Ireland
Read more

03/12/2025

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV