manufacturing experience in biotech or pharmaceutical industry and a
good understanding of the applicable manufacturing/testing processes
(i.e. API, Drug Substance, Drug Product, Packaging, Device
manufacturing processes?
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.
MANUFACTURING QUALITY ENGINEER - BIOTECH - 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.
This position will report to the Contract & Development Manager
Manufacturing.
The ideal candidate will have previous experience in aseptic
processing in a sterile manufacturing facility with cGMP and Quality
System knowledge.
The candidate will have excellent troubleshooting skills using
standard industry techniques.
Position will be responsible for managing and executing
nonconformance, CAPA, SICAR, Change Control and metrics oversight
responsibilities for the External Supply organization.
Determines situations which require escalation to management.
Communicate with all levels of the organization, facilitate
development of solutions to critical business issues, and effectively
define objectives to enable effective metric generation and reporting.
Facilitate daily scheduling meetings. Ensure current schedule is
maintained, accurate, and up to date.
Be responsible for compiling, maintaining and reviewing all necessary
reports.
Assist, plan and implement continuous improvement ideas /
opportunities.
Contribute and assist with Corporate, FDA, IMB Auditors and other
regulatory bodies during company audits.
Complete any other duties as requested by Site Manufacturing
Management.
REQUIREMENTS
Master’s degree OR Bachelor’s degree & 2 years of directly related
experience OR
Associate’s degree & 6 years of directly related experience
2+ years of quality and manufacturing experience in biotech or
pharmaceutical industry
Understanding of the applicable manufacturing/testing processes (i.e.
API, Drug Substance, Drug Product, Packaging, Device manufacturing
processes
Be a results-oriented person with excellent organizational,
communicational and team development skills with an ability to
successfully interact with people, create a team environment and
generate co-operation
Demonstrated ability to deliver to team, site and personal objectives
Able to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated understanding and use of RFT techniques and lean
manufacturing concepts
Strong ability to lead, challenge and positively influence in an
interactive team environment
Strong computer skills - knowledge Quality tracking system (QMTS).
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 35 - 45 Per Hour
Category: Construction
