Qa Validation Engineer

7 days ago

Sligo, Sligo, Ireland Dillon Engineering Services Full time

Overview
We are looking for an
experienced QA Validation Engineer
to play a
key role
in the development and upkeep of the site validation programme, ensuring all regulatory, quality, and compliance requirements are met.
Responsibilities
Coordinate, oversee, and participate
in the validation and QA of
site equipment, utilities, processes, and software
in compliance with
FDA, European cGMP, and GAMP standards
.
Develop, maintain, and execute
the
Site Validation Master Plan
.
Develop, maintain, and execute
project validation plans and schedules
.
Prepare
validation
protocols
and
final reports
to
cGMP standards
.
Conduct
validation
investigations
and
implement corrective actions
.
Create, review, and approve
quality documents and test data.
Manage
validation, exception event, and change control processes.
Maintain and track
validation equipment, where applicable.
Complete
all required training before performing any task.
Document
all activities in line with
cGMP requirements
.
Update
validation procedures, work instructions, and batch documentation to reflect
best practices
.
Provide
cross-training within the team and
support
the training of new members.
Participate
in continuous improvement initiatives for
manufacturing, quality, safety, and training systems
.
Coordinate
activities to
maximise team effectiveness
.
Ensure
overall
cGMP compliance
within production areas.
Communicate
with peers and management,
escalating events or concerns
where necessary.
Requirements
Qualification and/or degree
in an
engineering
or
scientific discipline
.
3+ years' validation or quality experience
in
medical device plastics processing, moulding, or assembly operations
.
3+ years' knowledge
of
cGMP
and
regulatory requirements
relating to the
medical device industry
.
Strong
written and verbal
communication
,
presentation
, and
troubleshooting skills
.
Effective interpersonal and organisational abilities
.
Able to work
both
independently
and as part of a
team
.
Capable of prioritising tasks
and
managing multiple responsibilities
simultaneously.
Strong communication and motivational skills
to
identify, document, action, and resolve
validation or QA needs promptly.
High level of autonomy
,
initiative
, and commitment to
'Right First Time'
principles.
Adheres
to all
procedures, policies, and guidelines
ensuring
compliance
with
cGMP, ISO/FDA regulations
, and company standards.
Persistence and determination
to ensure
timely closure
of issues.
To discuss this role in more detail, contact
Corné
at or for a confidential discussion.
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