CSV Engineer

4 weeks ago

Cork, Cork, Ireland Blackfield Associates Full time

Direct message the job poster from Blackfield Associates

Blackfield Associates are currently recruiting for a Computer System Validation (CSV) Engineer on behalf of a pharmaceutical client based in Cork, Ireland. This is a freelance/interim full time contract position requiring 3 days per week onsite / 2 remote as part of a capital projects team supporting GxP computerised systems.

Key Responsibilities:

  • Lead and execute validation activities for GxP computerised systems, ensuring compliance with site procedures and regulatory standards.
  • Collaborate with engineering teams and equipment vendors to deliver qualification deliverables.
  • Develop and manage key validation documentation, including User Requirements Specifications (URS), Validation Plans, protocols, reports, and Risk Assessments.
  • Support change control processes and TrackWise records for system updates.
  • Ensure data integrity by maintaining Requirements Traceability Matrices and Data Lifecycle maps.
  • Draft or revise SOPs aligned with industry and site standards.
  • Attend Factory Acceptance Testing (FAT) locally or internationally as required.
  • Deliver validation projects on time, maintaining compliance with cGMP and regulatory guidelines.

Key Requirements:

  • Degree-qualified or equivalent with 5+ years of CSV experience in the biotech/pharmaceutical sector.
  • Strong knowledge of GxP systems, regulatory expectations, and validation lifecycle practices.
  • familiarity with 21CFR, GxP and other related guidelines and regulations.
  • Proven experience delivering complete validation documentation for GxP system implementations or modifications.
  • Excellent communication, problem-solving, and stakeholder collaboration skills.
Seniority level
  • Seniority levelAssociate
Employment type
  • Employment typeContract
Job function
  • IndustriesPharmaceutical Manufacturing

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