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Regeneron Ireland

Software Validation Project Manager

Regeneron Ireland

  • Limerick
  • See description
  • Permanent full-time
  • Updated 11/12/2017
  • Regeneron Pharmaceuticals
this job is expired
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Description

This position implements policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems.

 

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: This position implements policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Essential Duties and Responsibilities include, but are not limited to, the following:
* Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Coordinates with other departments or outside contractors/vendors to complete validation tasks.
* Participates in regulatory audits and communicates company's computer validation policies.
* Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
* Manages projects and prepares status reports.
* May supervise, lead, or manage lower-level personnel.
* Trains /advises less experienced Specialists and Technicians.

Education and Experience:
* Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computers Qualification/validation; will substitute relevant experience for education.
* Experience in a GMP environment essential.
* Biologics experience highly desirable

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: 10999BR_1511857902
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Regeneron Ireland

Regeneron Ireland

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