Document solutions using standards and templates including User Requirement Specifications, Detailed Design Specifications, functional and technical specifications, configuration test plans, SOPs, and training materials
Author and execute validation protocols (IQ/OQ/PQ) for GxP and 21 CFR Part 11 compliance; process LIMS change control requests and partner with Validation and Quality to ensure systems follow the development lifecycle approach
Administer LabWare LIMS including security roles, upgrades, and documentation; participate in or lead security access reviews and periodic audit trail reviews
Troubleshoot issues, perform root cause analysis, and provide user support; provide application support before, during, and after regulatory and partner inspections
Train and mentor IT Applications team members and end users; coordinate with business stakeholders to gather, assess, and implement enhancement requests
This role requires
BS/BA in Information Technology, Life Sciences, or a related field
Associate IT Developer: 0 - 2 years of relevant experience, preferably including LabWare LIMS
IT Developer: 2+ years of relevant experience, preferably including LabWare LIMS
Senior IT Developer: 5+ years of relevant experience, preferably including LabWare LIMS
May consider equivalent combination of education and experience
Experience writing, debugging, and maintaining LIMS Basic subroutines for triggers, calculations, workflows, and custom events; experience building and consuming REST/SOAP APIs and working with XML and JSON
Strong SQL skills including complex queries and stored procedures (Oracle, SQL Server, or similar)
Working knowledge of GxP, GAMP 5, and FDA 21 CFR Part 11; experience authoring and executing IQ/OQ/PQ protocols and test scripts
Experience with Crystal Reports for custom reports, labels, and Certificates of Analysis preferred
Experience with version control software such as SVN or Git; familiarity with biological laboratory techniques a plus
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
- Salary Range (annually)
- €37,000.00 - €88,400.00
