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Regeneron Ireland

Principal QA Validation Specialist - Cleaning

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 17/12/2017
  • Regeneron Pharmaceuticals
this job is expired
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Description

Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

 

Regeneron offers a unique, world-class opportunity for interested candidates. Regeneron has been consistently ranked a "Top Employer" in Science Magazine's rankings for pharmaceutical and biotechnology companies. Regeneron is fully committed to bringing its award-winning approach to Regeneron Ireland, its subsidiary in Ireland, and is looking for outstanding people who are excited by a start-up environment, recognize the opportunities that this offers and wants to be challenged.

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

Essential Duties and Responsibilities include, but are not limited to, the following:
* Responsible for all aspects of the Cleaning Validation programs onsite for a large scale Biopharmaceutical Drug Substance production facility.
* Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
* Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
* Reviews, edits and approves change controls, SOPs, reports and other documentation.
* Collaborates with functional departments to resolve issues.
* Trains/advises less experienced Specialists..
* May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
* Manage and drives projects and prepares status reports.
* May present at both internal and external (regulatory) audits
* Stays current with industry trends, regulatory requirement updates, and communicating same to team
* May manage full time employees and/or contingent workers.
* Performs other duties assigned by Management.
* Some travel may be required.


Education and Experience:
* BS/BA in Engineering, Chemistry, or Life Sciences with 8+ years of related experience within the field of Cleaning Validation in Biopharmaceutical, Aseptic Fill/Finish or API manufacturing;

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron Ireland is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, family status, marital status, age, disability, sexual orientation, religion, race, national or ethnic origin, gender identity or any other characteristic protected by law.



To apply for this position please click here

Ref: 9856BR_1511185803
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Regeneron Ireland

Regeneron Ireland

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