Manufacturing Software Validation Engineer I

Quality Consulting Group, LLC

Villalba (PR)

On-site

USD 65,000 - 95,000

Full time

14 days+

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Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join its team in Puerto Rico & USA, focusing on computer software validations within the pharmaceutical, biotech, medical devices, and manufacturing space.

The role requires experience with software validation, regulatory compliance, and strong technical writing and bilingual communication in English and Spanish. You will work on CSV protocols, reports, and cross-functional projects on 1st shift.

Qualifications

Bachelor’s degree in Engineering.
At least two years’ experience in regulated industry with software 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

Responsibilities

Perform CSV on dedicated FW Pulse computers with EC/EF revisions.
Prepare CSV protocols, execute tests, and generate reports validating new EC/EF versions.
Collaborate on FW Pulse projects and related validation activities.
Utilize ancillary software for FW-related components developed by sites.
Leverage MSCM documentation and execute an Installation Qualification-like process.
Design manufacturing processes, equipment layouts, and procedures.
Ensure compliance with applicable regulations and quality standards.