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
.