experience in areas such as drug product formulation, vial/pre-filled
syringe filling or lyophilisation?
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.
PROCESS ENGINEER/SCIENTIST - BIOTECH PLANT - 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.
Process Engineer/Scientist required to work within the Process
Development Commercial Support team based in Amgen Dun Laoghaire
(ADL). The team is responsible for providing process and product
support to drug product formulation and fill-finish operations in ADL
as drug product process SMEs
Key responsibilities listed below but primarily the Hiring Manager can
foresee support will be needed for the following:
1. Day-to-day operations support as a subject matter expert in drug
product formulation, vial filling, pre-filled syringe filling,
lyophilization and vial capping.
2. Key contributor to product and process investigations, responsible
for assessing product and process impact.
3. Leads continuous improvement projects to improve process
performance and productivity.
The chosen candidate would typically be involved in activities such as
(but not exclusively);
• Assess product impact associated with proposed changes to
commercial processes under the change control process.
• Generate product impact assessments associated with process
excursions and deviations, with reference to product technical
documentation.
• Support new product introduction team, as a process subject matter
expert; This would include but is not limited to, recipe development
and protocol execution, as well as troubleshooting and investigation
support.
• Review and approve changes to operating procedures, electronic
batch records, and product documentation.
• Risk assessments and mitigation projects relating to line
performance.
• Perform process gap analysis and developing strategies to close
gaps.
• Data trend analysis for all performance aspects of the area.
• Troubleshooting performance trends.
The chosen candidate will work in a collaborative manner within the
process teams structure and contribute as a member of cross functional
teams within the local organization and functional team globally.
REQUIREMENTS
Bachelor’s or Masters degree in Engineering, Science or related
discipline with 6 years experience in a similar role OR PhD and 3
years of directly related experience.
Demonstrated leadership skills with the ability to build teams and
operate across functional boundaries, both internal and external.
Preferred Qualifications:
Typically * years drug product experience in
areas such as drug product formulation, vial/pre-filled syringe
filling or lyophilisation
Qualification in Lean and 6-sigma methodologies would be an advantage.
New product introduction (NPI), process development, MSAT experience
in a GMP environment would be advantageous.
PACKAGE
Contract role
Hourly Rate € * - € *
per hour
Minimum * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 50 - 60 Per Hour
Category: Construction
