Gandiv Insights LLC · 21 hours ago
Product Engineer
Raleigh, NC
Contract
Hybrid
Mid Level
3+ years expGandiv Insights LLC is seeking a Product Engineer to support the design, development, and lifecycle management of products and systems used in pharmaceutical and biotech manufacturing environments. This role will focus on engineering support for GMP-compliant products, process improvements, and cross-functional collaboration with Quality, Manufacturing, and Validation teams.
Information Technology & Services
Responsibilities
Support product design and engineering changes for GMP-regulated products
Create and maintain engineering documentation (drawings, BOMs, specifications)
Participate in design reviews, risk assessments, and change control
Support validation activities (IQ/OQ/PQ, CSV/CQV) as needed
Collaborate with Manufacturing, Quality, and Regulatory teams
Investigate deviations, support CAPAs, and implement process improvements
Ensure compliance with FDA, cGMP, and ISO standards
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, or related)
3+ years of experience in pharma, biotech, or medical device environments
Experience working in GMP/GxP-regulated manufacturing
Strong documentation and communication skills
Preferred
Experience with FDA 21 CFR Part 210/211, 820, ISO 13485
Familiarity with CAD tools and PLM systems
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase