Small Equipment Commissioning & Qualification (C&Q) Engineer
Location: Dublin| On-site
Contract | Full-time
We are looking for an experienced
Small Equipment Commissioning & Qualification (C&Q) Engineer
to join our team at a
Sterile Drug Product manufacturing facility
. The successful candidate will support the commissioning, qualification, and validation of equipment and utilities in compliance with
GMP
,
EU
, and
FDA
regulations.
Key Responsibilities
* Develop, review, and execute
CQV protocols
and
testing documentation
for small process and lab equipment including benchtop, mobile, analytical, PAT, incubators, biosafety cabinets (BSCs), and temperature control units (TCUs).
* Ensure
commissioning and qualification
activities comply with site and global procedures.
* Manage
deviations, risk assessments, and change controls
related to equipment and utilities.
* Perform and document
FAT (Factory Acceptance Testing)
and integrate results into qualification packages.
* Support project deliverables including
safety, CQV schedule, and quality documentation
.
* Maintain compliance with
Good Manufacturing Practice (GMP)
requirements and ensure audit readiness.
* Collaborate with cross-functional teams including engineering, validation, and manufacturing to achieve project milestones.
* Complete all assigned
training
in line with site metrics and compliance standards.
Required Skills & Experience
* Proven experience in
CQV execution
from design through qualification and handover.
* Hands-on experience in
commissioning and qualification of small equipment
and
automation-integrated systems
within
Drug Product
or
Drug Substance
facilities.
* Strong understanding of
CQV lifecycle
,
validation documentation
, and
regulatory compliance
.
* Experience with
electronic validation systems
such as
ValGenesis
or
Kneat
.
* Excellent organizational, communication, and teamwork skills with the ability to work effectively in a
matrix environment
.
* Strong problem-solving and analytical skills with attention to detail.
Qualifications
* Bachelor's degree (BSc/BEng) in
Engineering, Science, or a related technical discipline
.
* Minimum
3–5 years of pharmaceutical or biotech industry experience
, preferably with exposure to
Sterile Drug Product filling operations
.
* Comprehensive understanding of
EU GMP
,
FDA
, and
GAMP 5
guidelines.
Why Join
* Be part of a high-performing CQV team driving excellence in sterile manufacturing.
* Opportunity to work in a cutting-edge facility with advanced automation and validation systems.
* Collaborate with experienced professionals on global-scale pharmaceutical projects