CQV Engineer
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin, Ireland |
| Sector | Engineering |
| Start Date | |
| Advertiser | Hilda Lynn |
| Telephone | +3539833013 |
| Job Ref | #1002011 |
| Job Views | 53 |
- Description
- We are seeking applications for an experienced CQV Engineer as a contract role for our client, who are a leading biopharmaceutical company based in Dublin. The successful candidate will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities and become a member of a combined CQV Team (vendor, craft contractor, operations and CQV personnel)
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
Taking part in a CQV Team, while planning your own activities
Managing open issues (punch Items, non-conformances etc)
Commissioning bio-process systems with DeltaV automation
Reviewing & approving automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
Draft and review CQV test documentation.
Ensuring activities are scheduled, tracked and reported appropriately
Achieving project deadlines
Inputting into the core aspects of Operations SOP's.
Adhering to all health and safety procedures.
Complying with industry specific standards and regulations.
Leading risk assessments, root cause analysis and investigations.
Creating and reviewing protocols, reports, project change controls and deviations.
Proactively highlighting any issues around compliance.
Participating in internal and external audits and inspections
Accepting challenging assignments
Keeping up to date with current thinking and best practice
What you need to apply:
Technical diploma or Degree in Engineering/Life Sciences
Minimum of 2 years commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility
First-hand experience of a Risk Based Verification CQV (ASTM E2500) project execution
Experience in using DeltaV automation platform and review/approval of associated documentation.
Experience in IMB/FDA environment is preferred
Brilliant technical writing and communication skills
Skilled in RFT generation of validation/verification documentation
Problem solving and Project Management skills.
A goal-oriented attitude with ability to prioritize and manage tasks
A detailed knowledge of specific Bio-Process and Clean Utility unit operations