Careers2019-05-15T10:35:54+01:00
  • CSV Engineer


    • ID:893570
    • Location: Cork
    • Category:CSV Engineer
    • Positions Available:1

    Overview

    KPC International currently require a CSV Engineer for a pharmaceutical site secondment in Cork. The successful candidate will provide IT compliance/validation support to the Automation & IT (A&IT) Team and the general site to ensure compliance with Computer Systems Validation (CSV) and Systems Development Lifecycle (SDLC), Cyber Security and Data Integrity.


    RESPONSIBILITIES:

    • Prepare plans for remediation of legacy systems and implementation of new systems
    • Deliver effective and efficient running of CSV Compliance operations in the A&IT team.
    • Provide Compliance support, guidance and expertise
    • Manage deployment of SDLC/CSV policies and procedures.
    • Generation and execution of documents such as User Requirements Specifications, Design
    Specifications, FAT, SAT, IQ, OQ, PQ etc.
    • Review and approval of technical documentation from Vendors

    CANDIDATE REQUIREMENTS:

    • Qualification in an Electrical, Instrumentation or Control discipline with previous site-based experience
    with 3 years’ experience.
    • Thorough knowledge of GAMP 5, 21 CFR Part 11 also required
    • A focus on lasting operational quality for the systems lifecycle
    • Excellent communication / interpersonal skills.
    • Enthusiastic and energetic with the ability to integrate quickly into a team environment.
    • Demonstrated flexible and innovative approach to work

    JOB DETAILS:
    • Start: ASAP
    • Contract Term: 12 Months
    • Days Per Week: 5

WE'RE HIRING