Job Details

Summary of Position with General Responsibilities:

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.

Essential Job Functions:

·   Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling

·   Coordinates purchase and delivery of Equipment/Tooling

·   Coordinates installation of Equipment/Tooling

·   Develops and Executes IQ and OQ Protocols and Reports

·   Develops and Executes Test Method Validations / Gage R&R

·   Generates and Issues for Approval SOPs and Manufacturing Procedures

·   Develops and Executes Component Qualifications

·   Develops and Executes PQ and PPQ Protocols and Reports

·   Develops Manufacturing Capacity Analysis

·   Develops and Executes Process Characterizations / Design of Experiments (DOE)

·   Develops documentation/justification for assigned capital projects

·   Complies with cGMP’s, Quality Standards , and established policies and procedures

·   Executes other duties assigned by his supervisor

Basic Qualifications:

·   Bilingual – English and Spanish (oral and written)

·   Technical writing skills

·   GMP, ISO, EHS and Statistical regulations knowledge

·   Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)

·   MS Project knowledge

·   Minitab Proficiency

Additional Desirable Qualifications Skills and Knowledge:

·   Lean / Six sigma Training/Certification

·   Project Management Training/Certification

·   Engineering Board Certification (EIT / PE)

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