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 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
