JT040 - MANUFACTURING SOFTWARE ENGINEER I

Quality Consulting Group, LLC; Northern (KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC seeks a highly motivated engineer to perform CSV on production-relevant computers in a regulated manufacturing environment. You will validate EC/EF revisions, prepare protocols, and report outcomes for manufacturing deployments, working with FW Pulse projects and MSCM procedures.

The role requires a Bachelor’s in Engineering, 2+ years in regulated industry, and strong English/Spanish technical communication skills, with knowledge of Windows installations and SDLC

Qualifications

• Bachelor’s degree in Engineering required.
• At least two years’ experience in regulated industry with software validations.
• Root cause analysis and technical writing skills required.
• Experience with waterfall SDLC expected.
• Experience in medical devices or regulated industries.
• Strong written and verbal technical English/Spanish communications.
• Ability to develop software qualification protocols and reports.
• Familiar with Windows 10/11 software installation and troubleshooting.

Responsibilities

• Perform CSV on computers reserved for FW Pulse with a revision of EC/EF different from production.
• Prepare CSV protocols, execute them, and prepare reports validating EC/EF equivalence.
• Work with FW Pulse project and related ancillary software.
• Use MSCM-validated components and follow the Global IT MSCM Procedure for CSV.
• Design manufacturing processes, procedures, and layouts for assemblies and equipment installation.
• Ensure processes and procedures comply with regulations.

Skills

Investigation and root cause analysis

Technical writing

Organization and communication

Waterfall/SDLC

Regulated industry experience

English/Spanish communication

Software qualification protocols

Windows troubleshooting

Education

Bachelor’s degree in Engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Perform CSV on computers that are reserved for FW Pulse and require the use of a revision of an EC or EF that is different from the one currently in use in production.
• Prepare CSV protocols, execute them, and prepare reports that demonstrate that the new computer will function exactly as intended. This means that the new version of the EC or EF, functions exactly the same as the current computers with the current version of FW, EC, and EF.
• Work with FACTORY works (FW) Pulse project.
• Use ancillary software components that work in conjunction with FW that are developed by manufacturing sites.
• The most widely used are Equipment Controller (EC) and External Functions (EF). Both of these components are validated using the Global IT MSCM Procedure.
• All documentation from MSCM is leveraged into CSV. However, CSV has one extra step that is exactly the same as an Installation Qualification process that requires having an approved protocol with representative test cases and an approved report, prior to releasing to manufacturing any computer that uses an EC o EF.
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Ensures processes and procedures are in compliance with regulations.

Qualifications

• Bachelor’s degree in Engineering
• At least two years’ experience in regulated industry working with software and computer validations.
• Investigation and root cause analysis skills
• Technical writing knowledge
• Organization and Communication skills
• Experiences with waterfall or equivalent SDLC methodology.
• Familiar installing and troubleshooting software and peripheral equipment in Windows 10/11 computers
• Experience in medical devices or other highly regulated industry
• Strong written and verbal technical communications skills in English and Spanish.
• Capable of developing software qualification protocols and reports.
• 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.