Job Title:
Operations Aseptic Specialist
Location:
Sligo, Ireland
Contract:
12 Months
Rate:
Up to €36 per hour
Overview
We are seeking an
Operations Aseptic Specialist
to join the biologics manufacturing team in Sligo. This role is a key part of strengthening the site's
aseptic capability
and ensuring that all products are manufactured to the highest sterility and regulatory standards. As an Aseptic Manufacturing SME, you will play a critical role in
shaping best practices, supporting operations
on the manufacturing floor, and driving a strong culture of aseptic excellence.
Responsibilities
* Act as a site
Subject Matter Expert (SME)
for Aseptic Manufacturing.
* Provide key input into
setting up the manufacturing process
.
* Provide key input for the
Manufacturing Batch Record
.
* Ensure Operations procedures comply with
Safety and Environmental Regulations
,
Aseptic and GMP regulatory requirements
, and
network best practices
.
* Ensure effective use of
Risk Management tools
to support aseptic performance and
sterility assurance
, including
pFMEA
and
What If/HAZOP assessments
.
* Partner with Quality SMEs, Engineering SMEs, Aseptic MQA, and Aseptic Mentors to ensure manufacturing shifts have the support needed to complete product batches
safely
,
compliantly
, and in an
aseptic manner
.
* Drive a
high-performance culture
through communication, colleague engagement, and a
speak-up
culture.
* Routinely observe aseptic technique and behaviour of shift teams, giving feedback during critical activities such as
Cleaning
,
Sanitization
,
Aseptic Set-up
,
EM plate handling
, and
Interventions
.
* Lead and support investigations into
sterility
,
media fill
,
EM excursions
, and
EMPQ
issues, contributing to
root cause
and
CAPA
development.
* Own analysis and trending of
Environmental Monitoring (EM) data
, including responsibility for the
EM Visualization Tool
. Develop and execute
action plans
to address EM trends.
* Drive continuous improvement of aseptic procedures by:
* a) Assessing and applying
new Aseptic Manufacturing regulations
* b) Developing and implementing
best practices
* Ensure all procedures and changes follow
site Change Control
procedures.
* Provide key input into the
Site Contamination Control Strategy
.
* Provide key input into the
site APS strategy
.
* Provide key input into
Site LRP
for Aseptic Manufacturing.
* Provide key input into
cleanroom/equipment/utility design
,
qualification
,
re-qualification
, and
preventative maintenance
strategies.
* Support regulatory audits as an
Aseptic/Sterility Assurance SME
.
* Support training of Operations personnel in
aseptic technique
and
aseptic processing procedures
.
* Participate in routine leadership
GEMBAs
of manufacturing and testing areas.
Qualifications & Experience
* Third-level degree
in Science, Quality, or Engineering.
* 5+ years in a GMP environment
, with
3+ years supporting Aseptic Manufacturing (non-negotiable)
.
* Strong knowledge of
EU GMP Annex 1
, FDA
21 CFR Part 610
,
210
,
211
, and FDA guidance "
Sterile Drug Products Produced by Aseptic Processing - CGMP
."
* SME-level experience with
risk management tools
including contamination control strategy,
pFMEA
,
HAZOP
, and
What If
.
* Experience tracking and trending
environmental monitoring data
as a microbial SME.
* Experience in investigations related to
sterility
,
media fill
,
environmental monitoring excursions
, and
EMPQ
, including
root cause
and
CAPA
.
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.