Engineer II - Manufacturing Systems Software

Main Objective:

Provide technical leadership and architectural design, development and validation of software for manufacturing and inspection equipment and processes.

Essential Duties and Responsibilities:

• Develop Application Design Specifications, Test and Acceptance Plans, Software testing and code review.
• Project management of software validation activities and deliverables
• Ensure validations are compliant with appropriate regulations, such as ISO< 21 CFR Part 11, 820 and cGMP regulations, and corporate policy.
• Maintain current with ISO/FDA and internal quality assurance policies.
• Responsible for software development life cycle for both new applications and modifications to existing ones
• Participates in gathering user/customer functional requirements
• Develop/estimate project schedules/tasks based on requirements
• Programming using C#, VB.NET, JavaScript, SQL and other similar languages
• Analyze business process potentials for streamlining and improvements in efficiencies through value stream mapping and documented data/process flows.
• Prepare, assist, or participate in system design, specification development, and design review of control systems hardware and software for manufacturing and inspection equipment.
• Assess the impact of system changes thru change management and change control systems and develop risk mitigation and contingency plans
• Documentation and change management of custom code.
• Software and hardware architectural design

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Education and Experience:

• Bachelor’s Degree required in Computer Science, Engineering, or related Technology discipline required.
• Experience in an FDA regulated environment with a focus on software validation preferred
• Experience with MES Systems preferred
• 3 years overall experience required in building and enhancing custom solutions utilizing any of the following technologies:
  1. .Net/C#/VB.NET and other Microsoft platforms in Visual Studio
  2. Web technologies such as HTML, CSS, JavaScript
  3. SQL/Java/Oracle Programming

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Excellent communication skills and customer service orientation
• Training, certifications, and/or coursework in Six Sigma, SQL/C#/VB.NET, Oracle, Java preferred
• Must have thorough understanding of FDA regulations and computer validation guidance documents

Machine, Tools, and/or Equipment Skills:

Configure Microsoft PC servers, Programmable Logic Controllers and Industrial IoT devices. Work with standard current computer applications, word processing, spreadsheets, and enterprise applications such as ERP, MES, PLM and CRM.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.