Job Details: Process Engineering Senior Specialist


JobsIreland
Jervis Street
Dublin 1
Process Engineering Senior Specialist
Pharmaceutical

Construction of the company&#**Apply on the website**;s first ever
Large-Scale Mammalian-Based Drug Substance Facility will commence in
Dublin. This is a unique opportunity for the right person to shape,
create, build and grow the capabilities of the company&#**Apply on the
website**;s new site.

This role will report through the site manufacturing and technology
head.

Responsibilities:

Support the design, construction and qualification of upstream and
downstream equipment at the Dublin facility through to technology
transfer and commercialization

Support establishment of the commercial process and routine
manufacturing by:

* Support experimental design, execution, data analysis and
interpretation

* Interpreting trends observed in commercial process monitoring (PPA,
CPV, SPC, MVDA)

* Supporting deviation management

* Support change control prioritization and implementation

* Authoring and reviewing of batch documentation, technical reports
and global regulatory submissions

* Supporting multidisciplinary teams for process improvement and
troubleshooting with end-to-end product focus

* Apply Lean Six Sigma tools

* Serve as a key member during internal audits and external
inspections

* Lead & support various manufacturing science and technology
organizational initiatives as needed

This role may require shift work support after the facility start-up
phase is complete

Qualifications, Skills & Experience:

* Bachelor&#**Apply on the website**;s degree in Science, Engineering
or other Technical related discipline

* Minimum of 7 years&#**Apply on the website**; experience (5 years if
Master&#**Apply on the website**;s degree obtained) within the
pharmaceutical or biotechnology industry

* Experience with upstream cell culture and/or downstream purification
of biological molecules

* Experience with technology transfer, regulatory filing and
commercial drug substance manufacturing of biologics is a plus

* Technical operations experience in the drug substance manufacture of
biological molecules at commercial-scale

* Prior experience in drug substance process development, process
characterisation studies, process performance qualification and
validation, site readiness, batch record reviews and working with
external contract organisation for development/manufacturing

* Working knowledge of statistical methods for DOE design and data
analysis

* Working knowledge of statistical process control, multivariate
analysis, and/or process analytical technologies techniques for
biologics process

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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