CSV Engineer

Job Description

Job Title: CSV / IT Validation Engineer Senior

About Company: Our client is a multinational pharmaceutical company with an API manufacturing based in Dublin.

Duration: 3-6 months

Summary Objective:

As a CSV validation engineer, you will be responsible for ensuring that the Validation Activities are in compliance with Quality System requirements and recognised international standards.

The CSV / IT Validation Engineer Senior will report to a Project Manager and local Quality System & Compliance Manager.

Other team members include local QA/Validation, local MES/LIMS Administrators, IS/IT, Systems integrators, Solution Vendors, Process & Equipment Subject Matter Experts, and Management Stakeholders.

Job Duties:

• Validation of IT related equipment servers, switches preparation of the supporting documentation.

• Perform assessment and evaluation of Computerised Systems to meet requirements (e.g., FDA 21.CFR.Part 11 and EU Annex 11, GAMP 5)

• Develop Assessment & Evaluation Report: Assessment results/findings (Data Integrity) Compliance Gap Analysis & Documentation Gap Analysis (Proposed remediation actions/Proposed remediation plan).

• Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ, Cleaning Validation protocols; drive approval of same.

• Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.

• Adhere to the sites system development cycle

• Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to Site Validation Guidance Documents.
 

Basic Requirements:

• A third level qualification in Science, IT, Engineering or a relevant Quality discipline.

• 5+ years of experience in CSV strategy, planning, and execution within a Pharmaceutical manufacturing.

• Strong practical understanding of electronic records and signatures regulations (e.g. FDA 21.CFR.Part 11 and EU Annex 11), prevailing regulatory guidelines (e.g. Data Integrity guidelines), and good practice for GxP computerised systems (e.g. GAMP5).

• Experience in Pharmaceutical processes and environments is a must.

• A pragmatic and collaborative project temperament is expected from the candidate in terms of team and stakeholder engagement, verbal communication, strong GxP documentation skills, report writing, and interpersonal skills.

Desirable:

• Experience in the following processes is an advantage: API, tablet production, primary/secondary packaging, and clean room biotechnology environments.

• Experience in working within a Quality Department in the pharmaceutical industry is desirable.