with Environmental Monitoring and Bioburden testing of water &
disinfectants?
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.
QC SPECIALIST - BIOTECH ENVIRONMENTAL MONITORING - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
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.
This role will support manufacturing operations on a **Apply on the
website**/7 shift pattern and may include extended hours.
Environmental Monitoring of Grade 8/9 Cleanrooms
Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
Reading of Environmental Monitoring Plates
Bioburden testing of water & disinfectants
Writing technical reports
Utility sampling & testing
Testing of In Process samples such as Protein Concentration, Density &
pH
Compressed gas sampling
BI testing
Support QC Specialist with risk assessments/procedures for new
facility
Working with the project team to ensure we have sufficient resources
and equipment for the project
Completing qualification works for the new isolator, media
qualification etc
REQUIREMENTS
Bachelors degree in a science discipline
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and
testing of pharmaceutical products
Experience working in an aseptic cleanroom performing Environmental
Monitoring
Proficient in the use of LIMS & LMES
Technically strong background in microbiology and aseptic
manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an
advantage
Flexibility – the EM role often encounters changing priorities on a
daily basis
Good cross functional communication skills are essential
Presentation skills
Problem solving skills
Experience with Regulatory inspectors and interacting with inspectors
desirable
Demonstrated ability to work independently and deliver right first
time results
Works under minimal direction
Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories and precedents as
needed
May set project timeframes and priorities based on project objectives
and ongoing assignments.
Recognizes and escalates problems
Demonstrated leadership and communication skills
Auditing documentation and operation process
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 25 - 32 Per Hour
Category: Construction
