Senior CQV Engineers- Greenfield project

Dublin  ‐ Onsite
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Description

Our client, a world leading bio pharmaceutical organisation, is currently at the design stge on a major new build bio pharmaceutical facility in Ireland. They are seeking multiple Senior level CQV Engineers to act in the work stream lead capacity on various aspects of the building.



These are  12 month contract opportunities with potential to extend  for much longer.

They are looking for a number of different disciplines which will all be utilised within the project, these areas are:



- - HVAC

- - Utilities

- - Upstream

- - Downstream

- - Process Equipment

- - Turnover

- - Automation



Responsibilities



Lead a CQV Team with key emphasis on:



- Co-ordination of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel)

- Management of Weekly Activity Planning

- Mitigation of open issues (Punch Items, Non-Conformance's etc)

-  To commission Bio-Process systems with DeltaV automation

-  To review & approve automation  for DeltaV (CM’s, EM’s, Graphics & Phases)

-  To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations

-  Draft, review and approve CQV test documentation.

-  Accountable for scheduling, tracking, reporting and achieving project deadlines

-  Input into the core aspects of Operations, Qualification and Validation SOP's.

-  Safety

-  Planning and execution of all commissioning activities in adherence to site safety procedures.

-  Operate in a manner consistent with the site incident and injury free philosophy.

- Compliance

-  Understanding and applying industry specific compliance standards/regulations to all CQV activities



Requirements 



-  First-hand experience of a Risk Based Verification CQV (ASTM E2500) project execution

-  Leading Risk assessments, root cause analysis and investigations.

-  Generation and signing off of protocols, reports, project change controls and deviations.

-  Proactively highlighting any issues around compliance.

-  Participates in internal and external audits and inspections where required.

-  Learning and self-development

-  Willingly accepting challenging assignments

-  Proactively keeping up to date with current thinking and best practice

-  Commissioning, qualification and validation experience in biopharma projects.

-  Experience in IMB/FDA environment advantageous.

- Strong technical writing and communication skills

-  Ability to pay high level of detail and QA data to very high standard

-  Problem solving and Project Management skills.

-  Must be goal-oriented and able to prioritize and manage risks

-  Technical diploma or Degree in Engineering/Life Sciences or greater preferred.

-  Problem solving and Project Management skills



Please apply now to be considered for these excellent, long term roles on one of Irelands highest profile projects.
Start date
n.a
From
Quanta Consultancy Services
Published at
14.01.2016
Contact person:
Lee Mitchell
Project ID:
1051523
Contract type
Freelance
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