What are the responsibilities and job description for the Validation Specialist position at Indotronix Avani Group?
Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.
Bilingual - English and Spanish (oral and written)
Education and/or Experience:
- Bachelor’s Degree in Engineering
- Experience in the Medical Device / Pharmaceutical Industries: Yes
- 5 years of experience in the following fields: Manufacturing, New Product Transfers, Product / Process Development
- Job Functions Experience in the following:
· Qualification / Validation (IQ/OQ/PQ)
· Test Method Validation / Gage R&R
· Process Characterization / Design of Experiments (DOE)
· Manufacturing Line Design / Capacity Analysis
· Equipment / Tooling Design
· Equipment Installation / Preventive Maintenance Procedure Generation
· Root Cause Analysis / Investigation
· SOP / Manufacturing Procedures Generation & Change Control
· Product Financials & Supply Chain Structure Design
· OEE Integration, Vertical Start up and Zero-loss mindset