Software Engineer at Noven Pharmaceuticals, Inc - Miami, FL in Miami, Florida

Job Description:

This position is responsible for working in a cross-functional environment and partnering with internal users to provide day to day support, operate and manage internal applications, develop recommendations and improvements, and implement, sustain and refine applications for the Noven business units. The job priorities in order will be: ongoing applications operations, information integrity, consulting with internal users and teams, improving existing processes, integrating and consolidating services, projects, and self-improvement.

Responsibilities

• Analyze, plan, implement, control, monitor, and maintain commercial off-the-shelf applications, presentation services, and databases to ensure their continuous operations, availability, responsiveness, and usability to meet or exceed business expectations. Specific skills required in the Quality Systems systems which consist of Empower, Labware LIMS, Rees, NuGenesis,  Novatek Statistical  systems and reporting tools such Crystal Reporting and Power BI.


• Integrate systems and applications with the infrastructure and the operations team to create and optimize services and services levels.


• Create and enforce architectures, standards, methods, and services to assure new applications and services work efficiently.


• Create and manage information delivery frameworks. Assist users in creating dashboards, business intelligence, and reports.  Assist with SQL tuning and information delivery design.


• Design, implement and modify screens, interfaces, and other software assuring the quality, lowering the cost, easing maintainability, and building software quickly.


• Take a lead role in the planning, design, development, and deployment of manufacturing quality systems which consist of Empower, Labware LIMS, Rees, NuGenesis,  Novatek Statistical  systems and reporting tools such Crystal Reporting and Power BI. Partner with the project team to define business requirements and systems goals and identify and resolve business systems issues.


• Review and analyze the effectiveness and efficiency of existing systems and develop strategies for improving or further leveraging these systems.


• Maintain and improve systems and technical skills and then work with Business Services and the business owners suggesting service improvements.


• Work closely with IT Compliance, System/Process Owners and QA to assure and maintain validation requirements that are practical and follow industry and regulatory guidance.


• Analyzes, defines, develops, implements and manages applications software development, enhancement, implementation and/or life cycle maintenance activities


• Manages development and maintenance of application software access controls.


• Meet and communicate frequently with customers and management to review the ongoing operation, planned improvements and changes, incidents and responses, and other system related information.

Qualifications

Competencies:

• Ability to interact with and positively influence colleagues essential to advancing key projects


• Strategic/Evaluative Thinker

• Strong Written/Oral Communication/ Presentation Skills


• Software Engineering, development methodologies and SDLC


• Analytic and problem-solving methods


• 21 CFR Part 11, GAMP 5


• Programming:  C#, VB, Python, JavaScript, .Net, MVC,  EF, LINQ, SQL


• Data: SQL Server, Oracle, SQL Server Integration Services, Scripting


• Reporting Tools:  Crystal and Power BI


• Operating Systems: Windows, Linux


• Empower, Labware LIMS, Rees, NuGenesis, and  Novatek Statistical  systems  – Functional and Technical Skills (Development, Implementation, Support)

Education / Experience:

Bachelor’s degree in Computer Science, MIS or other related discipline (MS/MBA preferred) with 5+ years of technical experience in major business applications and software implementations. Experience with engineering and development of software is required. Empower, Labware LIMS, Rees, NuGenesis,  Novatek Statistical  systems and reporting such Crystal Reporting and Power BI. is a plus.  Knowledge and Understanding of GxPs and CFR 21 Part 11 regulations. Qualities essential to this position include a strong focus on customer service, quality driven and detail-orientation, along with strong technical and analytical aptitude. Excellent written and verbal communication skills with specific departmental knowledge.  Good judgment and strong attention to detail required; effective organizational capabilities.

Judgment/Decision Making

Design, develop, implement and support software systems and solutions to support multiple departments in the organization

Work Environment:

 Air-conditioned office environment.  Most of the time spend sitting at desk.  Up to 25% domestic travel required.   

 

Physical Demands:         

Regularly required to stand while making presentations.  Visual acuity and manual dexterity required to proofread a high volume of documents and operate the computer.