Systems Engineer

Compensation

$154,461.00 - $154,461.00 / Yearly

Hours Per Week

40

Number Of Positions

1

Job Description

LS Solutions, Inc. in Princeton, NJ is seeking a Systems Engineer to analyze user needs and develop software solutions, applying principles and techniques of computer science, engineering, and mathematical analysis. Individual(s) will apply advanced-level, theoretical knowledge of STEM (Science, Technology, Engineering and Math), as well as a deep understanding of system administration and SME.

Job responsibilities and duties include:

• Configuring Veeva Vault Systems by creating document and object workflows, object fields, and dependencies, and lifecycle management.

• Migrating data from the old legacy systems to the Veeva Vault database.

• Integrating the Veeva Systems with the downstream applications for the continuous flow using web actions, inbound packages and end points.

• Using Veeva API for the database updates and resolving complex issues.

• Categorizing the requirements as configuration/non-configuration ones and ensuring the QA established process is always met.

• Creating various visualizations in reports and dashboards to allow business to track the submissions deadlines.

• Creating new submission types in alignment with application types to ensure business needs are met.

• Creating the Index server and ADTS Server for the Primary D search and secondary search.

• Performing requirement gathering, feasibility and effort estimation.

• Aligning Vault systems with complex business requirements and ensuring timelines are always met.

• Creating validation documents like URS, TM, PQ Scripts, test plan, validation plan, configuration specification document.

• Working on incidents/change and following the established process using Service Now.

• Making the system ready for Health Authority Inspection by aligning security and creating Inspector Users.

• Updating controlled vocabularies, picklist, constraints, and objects to meet the business requirements.

• Creating records wizard to track the events created for various commercial products in the market and ensuring all activities are assigned appropriately.

This position does not supervise any personnel or participate in any management decisions, nor does this position plan, direct or coordinate the activities of any personnel.

Minimum Requirements:

Master’s degree in Biology, Chemistry, Pharmacy, or any STEM (Science, Technology, Engineering and Math) field of study, plus at least three (3) years of experience in the job offered or in any related position(s).

In lieu of the above-stated primary education and experience requirements, employer will accept a Bachelor's degree in Biology, Chemistry, Pharmacy, or any STEM (Science, Technology, Engineering and Math) field of study, plus at least five (5) years of post-degree, progressively responsible experience in any related position(s).

Qualified applicants must also have demonstrable proficiency, skill, experience, and knowledge with the following:

1. System Administrator and SME for various ECMS tools: Veeva Vault, Documentum, and Alfresco.

2. Validation planning and execution in compliance with FDA 21 CFR Part 11, GxP, and GAMP 5 guidelines.

3. SDLC and Agile methodologies

4. Requirements gathering and business analysis

5. Data migration and reconciliation

6. Regulatory compliance and documentation management

7. Stakeholder management and end-user training.

No travel. No telecommuting. Job duties are project-based & performed on long-term assignments at various unanticipated sites within the US which may require relocation at the end of the project.

Additional Information:

• Job Site: 731 Alexander Road, Ste. 101, Princeton, NJ 08540

• Salary: $154,461.00 per year.

• Benefits: Corp benefits offered: PTO, dental, vision, med/RX, 401(k)

• Send Resumes To: [email protected] and note job title.

• No calls. EOE.

• Must be legally authorized to work in the United States without sponsorship.

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Place of Work

On-site

Requisition ID

n/a

Application Email

[email protected]