CQV Engineer
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| Job Type | Contractor |
| Area | Dublin |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2887 |
| Job Views | 2015 |
- Description
- Team Horizon is seeking a CQV Engineer for an initial 12-month contract for our Clients manufacturing facility in Dublin.
What you will be doing:
Own individual workstreams within the Purification CQV Team with key emphasis on Planning 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)
Subject Matter Expert (SME) for individual unit operations (E.g. Ultrafiltration/Diafiltration, Chromatography etc.)
Oversee the start-up and commissioning of Purification systems in a Biological and / or Pharma Environment with DeltaV automation
Oversee the review & approval of automation FDS for DeltaV (CM’s, EM’s, Graphics & Phases)
Experience in System Startup, Commissioning, Functional Testing & Qualification necessary, including safe systems of work
Takes part in troubleshooting and remediation project teams.
Accountable for ensuring activities are scheduled, tracked and reported appropriately, and achieving project deadlines.
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 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.
Any other duties as assigned
What you need to apply:
Commissioning, qualification, and validation experience in Bulk Drug Substance Manufacturing Facility
Relevant experience as subject matter expert / engineer in a high-tech industry such as Biotech or Pharma, preferable.
Experience working on and knowledge of Purification systems and cleanrooms, including start up.
Experience in using Delta V automation platform and review/approval of associated documentation essential.
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.
Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
