QC Validation Specialist – Gene Therapy (Onsite, Shannon)
We're supporting a growing gene therapy manufacturing site in Shannon with the hire of a
QC Validation Specialist
to strengthen analytical method validation and transfer into GMP QC laboratories.
This is a
hands-on, onsite role
suited to someone who has
direct experience writing and reviewing validation protocols and reports
, particularly for
HPLC-based methods
in a regulated environment.
Key focus areas
* Authoring and reviewing analytical method validation protocols and reports
* Method transfer into GMP QC laboratories
* HPLC method validation (RP-HPLC / SEC)
* Supporting gene therapy and advanced therapy products
* Ensuring compliance with GMP, data integrity, and ICH Q2(R1)
What's essential
* Proven experience
designing and writing validation studies
(not just executing them)
* Strong hands-on
HPLC experience
* Background in pharma, biologics, or gene therapy QC
* Comfortable working primarily onsite