I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
James Cassidy
Life Science

+353 1 5079250
james.cassidy@lifescience.ie
Connect with me on
Senior Chemist
Dublin North
Head of Quality
Dublin West
QA Manager Biologics
Dublin West
Principal Scientist
Dublin South
Snr QA Specialist
Dublin South
QA Specialist
Dublin West
R&D Engineer
Galway
Program Manager
Westmeath
QA Director
Dublin North
Technical Sales Engineer
Republic of Ireland
Snr Process Engineer
Dublin North
Qualified Person
Dublin West
QA Manager
Dublin West
Market Access Manager
Dublin City Centre
QA Manager
Meath
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Technical Manager (Drug Substance)


Reference:JC/HQ00001681 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Technical Manager (Drug Substance)

Our client a biopharma multinational with who have recently expanded their state of the art drug substance facility whose principal manufacturing technologies include large-scale mammalian cell culture, protein purification, vaccines conjugation, and aseptic syringe filling. Currently require a Technical Manager to join their team. Reporting to overall Site Engineering Manager the position is responsible for providing technology & production expertise in the production of quality-driven products that improve people's lives around the world. This is a key leadership role within the project organisation and the successful candidate is expected to strongly integrate the work of Process, Automation and C&V functions with those of Technical Services, Operations and Quality.
The Technical manager will join group at Concept Design stage of the project and will manage a team that will execute the remaining stages of the project, including those relating to future permanent colleague positions within the production unit, will be developed within the early stages of the design and an appropriate selection process will be followed to fill these positions.
The successful candidate will manage a team providing client engineering input to support the design effort and subsequent phases for each of the following elements, throughout the project delivery lifecycle of a new Drug Substance high capacity manufacturing facility:
· All Process unit operations, including cell culture, harvest, downstream purification and support systems.
· Automation, including systems infrastructure, platform selection, hardware design and systems integration for both process systems control and building management systems.
· The role also encompasses responsibility for the management of Commission and Verification (C&V) activities on the project
The role will direct key decisions within the concept design for this future new facility from the perspective of how the facility will ultimately be configured and operated, initially through conceptual design and subsequently preliminary & detailed design, construction, commissioning and verification/qualification, PV and start-up.


Role/Responsibilities
Team leadership of Process, Automation and C&V groups.
Provide client technical engineering input to scope definition, specification and procurement for all process equipment.
Review and approval of A/E firm process engineering design deliverables
Review and approval of equipment package bid analyses.
Provide engineering input into overall facility layout and design.
Support input to the development of detailed capital project execution schedule
Provide engineering input into cost estimate preparation for the project.
Manage process design quality and design change.
Develop general procedures, metrics and deliverables in support of successful delivery of the project objectives on time and within budget.
Identify project risks and opportunities and propose mitigation plans.


Skills/Experience:

Min qualification – BEng (or equivalent).
Experience of A/E Design Firm project execution
Solid (15 years) biopharmaceutical engineering project experience.
Knowledge of upstream and downstream processes within mammalian cell culture manufacturing facilities.
Knowledge and experience of project execution for fully automated facility design
Knowledge of Delta V.
Experience of facility design in a 3D Model / BIM environment
Experience of Equipment vendor package management and design coordination
Knowledge and experience of Bio-pharmaceutical commissioning & qualification, with knowledge of ASTM E2500 a particular advantage.
Good understanding of risk management methodologies, with a proven ability to apply in Bio-pharmaceutical operations.
Strong knowledge of problem solving, root cause analysis, operational excellence techniques. Six Sigma experience an advantage.



James Cassidy | Tel: +353 (0) 1 5079250