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 level
Associate
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing
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