Job Title:
Process Scientist/Engineer
Location:
Sligo, Ireland
Type:
Permanent
Salary:
Competitive Package
Overview:
A leading biologics manufacturing site in Sligo is seeking a
Process Scientist/Engineer (Single Use)
to join its Technical Operations team. This facility includes a
Centre of Excellence for Precision High Volume Moulding and Auto-Assembly
and a state-of-the-art
aseptic fill-finish operation
.
The successful candidate will work closely with
cross-functional site teams
and
global science and quality functions
on the development, qualification, and lifecycle management of
single use materials
within the product path for biologics manufacturing.
This role reports to the
NPI Technical Manager
and offers an exciting opportunity to contribute to a growing site introducing new products and technologies.
Key Responsibilities
* Collaborate with site and global teams to develop and evolve
single use materials
used in biologics manufacturing.
* Lead or support
risk assessments
for new or modified product paths, including single use materials (e.g., pFMEA, Extractables & Leachables assessments), and manage associated change activities.
* Serve as the
technical lead
for vendor and manufacturer interactions, including validation package review and complaint resolution.
* Contribute to development of manufacturing processes for new products, including drafting and reviewing
protocols, procedures, and batch records
.
* Create and maintain
specifications for new product introduction (NPI) materials
and consumables.
* Provide technical support to operations; lead investigations and design experiments for troubleshooting or validation.
* Monitor and analyse process data during manufacturing campaigns.
* Support, supervise, and train operations personnel in single use processes.
* Ensure compliance with all
EHS&E standards and policies
.
* Perform other duties as assigned.
Qualifications:
* Bachelor's degree
in science, engineering, or related technical discipline.
* Minimum
2 years' experience in biologics manufacturing
using single use systems in a GMP environment.
* At least
1 year experience in design, onboarding, and qualification of single use assemblies
.
* Experience working with
external vendors and global stakeholders
in a client-facing capacity.
**Only candidates with a
valid work visa for Ireland or an EU passport
will be considered.
To discuss this role in more detail, contact
Corné
at
or
for a confidential discussion.