Cqv Verification Engineer

ICDS Recruitment

Dublin West

Commissioning, Qualification and Validation (CQV) Verification Engineer - Dublin. This is a contract posting of 12 months' duration. Position Summary: The Verification Engineer will use the Risk Based Verification (RBV) approach to execute commissioning and qualification activities in this cGMP Bulk Drug Substance (BDS) manufacturing plant in Dublin. The role is a contract position as part of the CQV team and will be a specialist role in the Cell Culture/Bioreactor C&Q workstream. Principal Responsibilities: • Technical Application- 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. - 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, and experience in specific Bio-Process unit operations i.e. bioreactor operation and principles, axenic processing and CIP/SIP. - Experience working with bioreactor equipment growing mammalian cell lines. - Experience in System Startup, Commissioning, Functional Testing & Qualification execution of Bioreactors preferred, including safe systems of work. - Field Walkdowns of systems as part of transfer of ownership of the system from Construction. - Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines. - Support sprayball coverage testing on CIP and process vessels. - Input into the core aspects of Operations 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. - 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. • Learning and self-development. -Willingly accepting challenging assignments. - Proactively keeping up to date with current thinking and best practice. • Any other duties as required by management. Qualifications and Experience sought: • Commissioning, qualification and validation experience in Bulk Drug Substance Manufacturing Facility (minimum 2 – 5 years. • Experience in Cell culture or related bioprocess manufacturing experience in an established biotech production operation. • Experience in using DeltaV automation platform and review/approval of associated documentation essential. • 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 sprayball coverage testing in process vessels advantageous. • 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. Education. • Technical Diploma or Degree in Engineering/Life Sciences or greater preferred. This job originally appeared on RecruitIreland.com.

2039 days ago