Job Description
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.
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 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.
Requirements
Skills:
· Commissioning, qualification and validation
experience in Bulk Drug Substance Manufacturing Facility (min 4 – 7 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
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.