Senior CSV Specialist

3 days ago

Cork, Cork, Ireland beBeeCompliance Full time €96,490 - €118,928

Job Title: Senior CSV Specialist

About the Role:

We are seeking a highly experienced Senior CSV Specialist to manage qualification of GxP Computerised Systems involved in plant expansion and improvement projects.

Key Responsibilities:

  • Design, commissioning, qualification and validation documentation - drafting, reviewing, and approving CSV related elements of documentation as appropriate.
  • Co-ordinate and execute CSV related commissioning, qualification, and validation activities where applicable, including preparing of validation master plans and executing of DQ, FATs, and SATs.
  • Contribute to scheduling, tracking, reporting, and achieving project deadlines.
  • Provide input into core aspects of operations, qualification, and validation SOPs.
  • Attend departmental and team meetings focused on CSV activities.
  • Serve as a CSV representative for internal technical group discussions.
  • Understand and apply industry specific compliance standards / regulations to all commissioning / qualification activities.
  • Conduct and participate in risk assessments, root cause analysis, and investigations.
  • Review, approve, and sign off protocols, reports, project change controls, and deviations.
  • Proactively highlight any issues around compliance.
  • Participate in internal and external audits and inspections where required.
  • Work closely with QA departments and adhere to their requirements.

Qualifications:

  • Degree level qualification in Science, Engineering, or equivalent.
  • 10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
  • Experience in process automation.
  • Understanding and experience in GAMP, GDP, AND cGMP environments.
  • Experience with ISA S95 and S88 standards.
  • Experience of testing GAMP Category 3, 4 & 5 systems.
  • Knowledge of CFR 21 Part11.
  • Solid organisational skills including attention to detail and multitasking skills.

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