qualification and the validation lifecycle process in line with ASTM
E * and qualifying sterilisation equipment,
isolators, HVAC systems and/or providing validation support for
aseptic process simulation?
This is a contract role based in Dun Laoghaire, Dublin.
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
VALIDATION ENGINEER - BIOTECH HVAC - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoghaire,
South Dublin.
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland&# *;s leading aseptic manufacturing
plant.
In this role, you will be responsible for delivering on the
qualification and validation program, which will include planning and
execution of sterilisation validation / requalification activities on
critical sterilisation/decontamination equipment.
The sterilisation team perform /validation/ re-qualification on
equipment such as VHP isolators, autoclaves, CIP/SIP systems and
Lyophilisers and provide validation oversight on aseptic processing
simulations.
This role will focus on HVAC requalification in the production
environments, including managing the routine re-qualification program
of airflow visualisation and filter integrity testing activities as
well as testing in response to changes to the production
environment.
Provide technical validation support to meet site objectives,
comprising of the full validation lifecycle process.
Develop, review and approve validation plans, protocols, discrepancies
summary reports in the area of sterilization validation.
Provide support for the aseptic process simulation program, including
aseptic intervention review, protocol generation, execution and
summary report generation.
Provide support for airflow visualisation studies and HVAC
requalification program.
Provide support for the execution of cycle development, performance
qualifications and requalification program in line with projects and
site validation masterplans.
Collate and report on relevant validation data and metrics.
Assist in the development and improvements of the validation lifecycle
process while ensuring continued compliance to all applicable
regulations and standards.
In addition, provide input and guidance into multisite and local
procedural requirements.
Provide validation support for site quality management system,
including change control, deviation and CAPA processes.
Coordinate projects and prioritize workload in line with site
priorities.
Participate, when required, as a member of multidisciplinary site and
multisite teams, e.g. cross functional investigation teams and change
control
Update and maintain validation Standard Operating Procedures (SOPs) in
accordance with site and corporate requirements.
Participate in regulatory inspections, regulatory filings
Attend and contribute to staff meetings and attend appropriate
training sessions, as required.
Comply with the responsibilities as outlined in the Site Safety
Statement and champion safe working practices and initiatives within
their functional area.
Perform all tasks with due care and attention and in accordance with
Good Manufacturing Practices
REQUIREMENTS
Bachelor of Science/Engineering degree or equivalent.
Knowledge of cGMP’s and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications
skills
3+ years’ experience in a similar role
Experience in equipment qualification and the validation lifecycle
process in line with ASTM E *.
Experience qualifying sterilisation equipment, isolators, HVAC systems
and/or providing validation support for aseptic process simulation.
Experience of Quality and Document Management Systems including
Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
Independent, self-motivated, proactive, organized, able to multi-task
in project environments and skilled in communication and
collaboration.
Team player, prepared to work in and embrace a team-based culture that
relies on collaboration for effective decision-making.
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 55 - 65 Per Hour
Category: Construction
