Job Description
Position Name: Sr Manufacturing Engineer
Location: Humacao , Puerto Rico
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
Job Tags
Contract work,
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