Browse by job sector

CQV Lead Engineer

  1. Ireland, West
Ireland
  1. Contract
Competitive
  1. CAPEX Projects
36572
Apply to this job Save job
CQV Lead Engineer - North of Ireland - 12 Months Contract

Do you want to be part of one of the top 10 best companies to work for in Ireland? We have a superb opportunity for a Manufacturing Biotech Associates to join our client, a global pharmaceutical organisation in their new multifunctional facility.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Work within a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project.
  • Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as SME on the process & equipment within the assigned area.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area.
  • Implementing the requirements as outlined in the site & project Validation Master Plan(s).
  • Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
Desirable Experience:
  • Extensive C&Q/ QA/ QC/ Validation experience in highly regulated industry.
  • Experience in process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction. 
  • Presenting of QA / QC / Validation documents to regulatory agencies/ inspectors and defending approach
  • SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators / Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection 
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA.
If this role is of interest to you, please apply now!
 #LI-DH1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Project Manager Officer

Salary

Competitive

Location

Paris

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

France

Description

Project Manager Officer - France, Paris - 6 Month Contract Our client, a global pharmaceutical company, are looking for a Project Manager Officer to join their team. The company has grown to

Reference

37431

Expiry Date

01/01/0001

Caroline O’Sullivan

Author

Caroline O’Sullivan
Caroline O’Sullivan

Author

Caroline O’Sullivan
Read more
Read more
Project Engineer

Salary

Competitive

Location

New Jersey

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Project Engineer - US, New Jersey - 6-12 Month Contract Our client is a multinational CDMO specialising in complex active pharmaceutical ingredients for pharmaceutical and biotech customers. Due

Reference

37384

Expiry Date

01/01/0001

Ben Pope

Author

Ben Pope
Ben Pope

Author

Ben Pope
Read more
Read more
Project Engineers

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Project Engineer - US North Carolina - 6 Months Initial Contract Our client, a global pharmaceutical manufacturing organization are looking for a talented Project Engineer to join their

Reference

37442

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

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