CSV Engineer – Cork

CSV Engineer – Cork2019-01-08T17:05:05+00:00

CSV ENGINEER – CORK

 

TARGET START DATE:                    ASAP

LENGTH OF ASSIGNMENT:            12 months + extensions / 39 hours per week

PROJECT LOCATION:                      Cork, Ireland

ROLE

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.

Duties:

  • 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

QUALIFICATIONS & EXPERIENCE

  • 3 years’ experience with a qualification in an Electrical, Instrumentation or Control discipline with previous site-based 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

To find out more about this new opportunity please send your CV to eoin.collins@kpc-international.com or for a confidential conversation call Eoin Collins on +353 21-2363152

WE'RE HIRING