CQV Engineer – Clean Utilities Biowaste
Dublin, IE
21d ago

The Opportunity

Team Horizon is seeking a CQV Engineer Clean Utilities Biowaste. The Verification Engineer will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in the company’s cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin, Ireland.

The role is a contract position as part of the CQV team and will be a specialist role in the Clean Utilities, Biowaste and Waste C&Q workstream.

The Role

  • Participate in a CQV Team with key emphasis on :
  • 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)
  • Start up and commissioning of Clean Utilities, Biowaste and Waste systems in a Biological and / or Pharma Environment with Siemens automation
  • Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
  • Takes part in troubleshooting and remediation project teams.
  • Generation of qualification documentation
  • Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines
  • Experienced in transfer of ownership of the system from CQV to Operations
  • 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.
  • Leading deviation 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
  • The Person

  • Technical diploma or Degree in Engineering / Life Sciences or greater preferred.
  • Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (min 2 5 years)
  • Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable.
  • Experience working on and knowledge of Clean Utilities, Biowaste and waste systems, including start up.

  • Experience in using Delta V automation platform and review / approval of associated documentation required.
  • Experience in issue description, root cause identification, technical / quality impact assessment & corrective action justification.
  • Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
  • Experience in IMB / FDA environment advantageous.
  • Relevant experience as subject matter expert / engineer in a high tech industry such as Biotech or Pharma, preferable.
  • Experience working on and knowledge of Biopharma unit operations, including start up.

  • Excellent technical abilities with a solid base in engineering.
  • Strong technical writing and communication skills.
  • Proven track record in generation of validation / verification documentation.
  • Must be goal-oriented and able to prioritize and manage tasks.
  • Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Application form