Role Overview
Impact Engineering is currently recruiting an experienced
CSV Engineer
(3–5 years' experience preferred) to join the CSV team at a
client site in Carlow
.
The successful candidate will bring strong
GMP manufacturing experience
within the life sciences sector and will play a key role in supporting site-wide
Computer Systems Validation (CSV)
and IT compliance activities.
This role provides
IT compliance and validation support
to the AIT team and the wider site, ensuring ongoing compliance with
CSV, SDLC, Cyber Security, and Data Integrity requirements
in support of the manufacture and supply of high-quality pharmaceutical products.
Key Responsibilities
Ensure compliance with
global SDLC, CSV, and IT Security policies and procedures
.
Deliver all required compliance activities through effective
planning, coordination, and execution
of project and operational deliverables.
Support and manage compliance processes including:
Change control
Periodic reviews
System performance monitoring
System and access administration
Disaster recovery activities
Deviations, incidents, investigations, and CAPAs
Audits and inspection readiness
Policy deployment
Cyber security and data integrity initiatives
EHS and training compliance
Operate in accordance with the
Quality Management System (QMS)
, ensuring adherence to:
Chapter 14 (Computer Systems)
EU Annex 11
21 CFR Part 11
MHRA (UK) GMP Data Integrity Guidelines
Sarbanes-Oxley (SOX) requirements
Requirements
Degree qualification in
Science, Engineering, or a related technical discipline
.
3–5 years' GxP experience
in Computer Systems Validation within the
life sciences, pharmaceutical, or medical device
industry.
Proven ability to work effectively within
high-performing, cross-functional teams
.
Comfortable engaging with
stakeholders at all levels
in a fast-paced, dynamic environment.
Strong collaboration and leadership skills, with a focus on
continuous improvement and best-practice implementation
.
Excellent
verbal and written communication
, along with strong
project management capabilities
.
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