Job Details: Senior Specialist - Validation


JobsIreland
Jervis Street
Dublin 1
Senior Specialist - Validation
Construction on a new Large-Scale Mammalian-Based Drug Substance
Facility in Dublin. The Senior Specialist Validation role will be
essential in ensuring efficient and effective compliant design,
construction, qualification, approval and operation of the new
state-of-the-art facility during the initial project phase.

Responsibilities:

Support the design, construction and qualification on the new Dublin
facility and manufacturing science and technology by:

* Developing and maintaining the site Validation Master Plan

* Driving completion of cleaning and sterilization cycle validation
activities

* Support equipment qualification post Operational Qualification (OQ)
through to Process Performance Qualification (PPQ) and revalidation

* Develop post OQ documentation in line with the company and
regulatory requirements

* Authoring and reviewing standard operating procedures and technical
reports

* Apply Lean Six Sigma in the validation group

* Lead and support various organizational initiatives as needed

Qualifications, Skills & Experience:

* Bachelor&#**Apply on the website**;s degree in Biological Sciences /
Chemical Engineering / Biological Engineering / Chemistry

* Minimum of 3 years&#**Apply on the website**; experience within the
pharmaceutical or biotechnology sector

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

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

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

* Temperature mapping experience

* Cleaning validation experience

* Partswasher and autoclave experience

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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