Quanta Consultancy Services Ltd
United Kingdom
03 Oct 2017
05 Nov 2017
Contract Type
Full Time
A major global biopharmaceutical organisation with global operations in Ireland is seeking multiple CQV Engineers (Commissioning Qualification Validation) for their substantial greenfield project in Ireland. This is one of the Ireland`s largest investment projects and is scheduled to complete in 2019. We are seeking experienced Engineers with varied backgrounds including process/ancillary equipment, biopharmaceuticals, including upstream and downstream and utilities, with varying levels of experience for this sizeable project. Key equipment requirements include: Bioreactors, vessels, centrifuges, chromatography columns, ultrafiltration, diafiltration, parts washers, hoists, mobile vessels. The Engineer will use the Risk-Based Verification (RBV) approach to execute commissioning and qualification activities on this start up biopharma project. The role is a contract position as part of the CQV team. Principal Responsibilities: - Membership of Combined CQV Team (Vendor, Craft Contractor, Operations and CQV Personnel). - Planning of Own Activities. - Ownership and Closure of open issues (Punch Items, Non-Conformances etc). - To commission Bio-Process systems with DeltaV automation. - To review & approve automation FDS for DeltaV (CM`s, EM`s, Graphics & Phases). - To have a detailed knowledge of specific Bio-Process and Clean Utility unit operations. - Draft and review CQV test documentation. - Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines. - Input into the core aspects of Operations SOPs. - 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. - Understanding and applying industry-specific compliance standards/regulations to all CQV activities. - First-hand experience of a Risk-Based Verification CQV (ASTM E2500) project execution. - Leading Risk assessments, root cause analysis and investigations. - Generation and review of protocols, reports, project change controls and deviations. - Proactively highlighting any issues around compliance. - Participates in internal and external audits and inspections, where required. - Willingly accepting challenging assignments. - Proactively keeping up to date with current thinking and best practice. Requirements - Commissioning, qualification, and validation experience in Biopharmaceutical Manufacturing Facility. - Experience in using DeltaV automation platform and review/approval of associated documentation. - Experience in IMB/FDA environment advantageous. - Strong technical writing and communication skills. - Proven track record in RFT generation of validation/verification documentation. - Problem solving and Project Management skills. - Must be goal-oriented and able to prioritise and manage tasks. - Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
This job was originally posted as www.jobsite.co.uk/job/959242404