Systems Analyst (Pharma)
We are currently looking to fill the position of Systems Analyst in our IT Lab Systems Group. As a Systems Analyst you will be a vital part of a team responsible for the implementation and support of multiple laboratory software applications. For this position we are looking for an experienced individual to serve as the System Administrator for the NuGenesis Scientific Data Management System (SDMS). This function requires close integration with and knowledge of other applications including Waters Empower Chromatography System, Nugenesis ELN and LabWare LIMS, as well as bench top computer systems and instrument software such as Endoscan, FTIR and NIR. Our team reviews proposed changes to existing configurations and authors specifications for upgrades and modifications. A significant focus of this role is ensuring quality and compliance in a highly regulated cGMP environment. The systems we support are crucial in the production of Regeneron's life-saving products.
As a Systems Analyst a typical day might include the following:
- Ensuring applications and systems remain in a compliant state by processing change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
- Collaborating closely with laboratory personnel to set priorities and support business-critical projects
- Providing end-user support including solving problems at the application level and hardware troubleshooting (includes working with vendors to resolve issues) and training them on system functionality
- Initiating, authoring, and reviewing documents such as Change Controls, investigations, deviations, risk assessments, impact statements and corrective/prevention action plans
- Participating in, leading, or authoring investigations and root cause analysis for department issues of non-compliance
- Drafting, approving and following relevant system software SOPs and policies
- Representing the team as the SDMS Subject Matter Expert during technical and planning meetings
- Ensuring system integration with other applications as required (e.g. LIMS/ ELN, Unifi)
- Administering user access including control access to software systems; adding, modifying and removing users; defining user types, user groups and security settings
- Supporting system validation and qualification efforts
This role might be for you if you:
- Enjoy working independently, while at the same time being part of a collaborative, engaged team intent on crafting and delivering quality applications
- Desire to be a key contributor within an organization delivering cutting-edge medicines
- Have an expertise in the use and/or administration of Waters Empower software
- Enjoy the challenge of learning new systems and applications
- Are familiar with regulatory and quality policies, procedures and documentation methods, ideally in cGMP biotech/pharma operations
- Enjoy helping end-users solve problems and are committed to finding innovative solutions to laboratory testing challenges
- Have some project management experience
- Possess stellar organizational skills
- Appreciate the importance of Quality Control in the laboratory and IT settings
Applicants ideally should have a BS/BA in Science, Information Systems or other relevant field and 2+ years of experience with NuGenesis SDMS in a GXP industry. Applicants with a relevant degree and 5+ years of experience with NuGenesis SDMS may be considered for Senior Systems Analyst. Experience in a pharmaceutical setting highly preferred. Without a degree we will consider at least 5 years of relevant experience in lieu of the educational requirement. Level will be determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.