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: The Senior Laboratory Systems Analyst will be a customer facing individual responsible for implementation and subsequent day to day support and maintenance of general Laboratory Computers systems in our QC, Chemistry, Micro and Process Sciences labs. These systems include the Waters Empower 3 Chromatography system, Waters Nugenesis and bench top computer systems and instrument software such as Endoscan, FTIR and NIR.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Coordinates the needs of functional departments and establishes priorities for Empower and Laboratory Systems requirements gathering, system design and implementation.
* Technical/project Lead on Instrument Qualification Projects.
* Responsible for Laboratory System documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports.
* Configures reports (tabular, trend and labels).
* Processes Laboratory Systems change control requests.
* Works with Validation and Quality departments to ensure Laboratory Systems are implemented following development life cycle approach.
* Trains other Laboratory System trainers.
* Coordinates with other Laboratory Systems team members to implement the system in an efficient manner.
* Provides end-user support for Laboratory Systems including troubleshooting problems at the application server level.
* Empower System Administrator including Systems security access, Audit trail and periodic audit trail review.
* Support day to day activities for Laboratory Systems
* Provides on-the-floor guidance and support to employees.
* Prioritize the day-to-day work assignments for analysts within the IT department to support lab system troubleshooting activities.
* Ensures employees timesheets are completed on time.
* Monitors employees training to ensure that all requirements are met, including OJT.
* Maintain up to date training records for self and direct reports.
* Perform minimally monthly performance feedback meetings with direct reports.
* Escalates all performance issues to management and/or HR.
* Ability to train, develop and mentor direct reports.
Education and Experience:
* BS/BA in related field and minimum 6 years of relevant experience preferred; will substitute relevant industry experience for educational requirement.
* Project Management experience. Professional qualification preferred.
Knowledge and Skills:
* Thorough knowledge of Empower 3, FTIR and NIR software systems
* In depth knowledge of concepts of GMP, ICH guidelines and GAMP requirements
* Excellent knowledge of laboratory automation/instrument qualification practices and cGMP applicable to a pharmaceutical environment.
* Knowledge of SQL, Oracle and relational database concepts;
* Logical troubleshooting and problem solving skills.
* Excellent written and oral communication skills
* Basic laboratory experience preferred, but is not required;
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.