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Engr 3, Product Development
Job
Planet Pharma Group
Paso Robles, CA (In Person)
Full-Time
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Job Description
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