Validations Specialist

Job Description

The Validations Specialist will work with our Clients and be responsible for preparing and executing validation documents. Demonstrate an understanding of cGMP. Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.

Job Type: Part Time – Temporary (3 to 6 Months)

Systems: DI Water System, Nitrogen System, Steam Generator (Boiler), Air Compressor, etc.

Essential Duties include, but are not limited to:
Develop Validation Master Plan (VMP)
Develop process validation protocols (IQ, OQ, PQ) for Automated Equipment.
Develop Manufacturing Standard Operating Procedures.
Develop Test Methods.
Develop Preventive Maintenance Procedures.
Execute and Planning Validation Activities.
Coordinate Equipment Installation and Calibrations.
Develop and system routing of Change Control and Change Request.
SAP system management.
Challenge and Red-Line Equipment Electrical Drawings.
Develop Equipment Quotation request from external vendors.
Train Manufacturing Personnel.
Edit Product Specifications.
Collaborate and participate on Technical Meetings.
Develop Design Specifications (DS)
Develop Functions Specifications (FS)
Develop User Requirement Specifications (URS).
Develop Factory Acceptance Tests (FAT).
Develop Impact Assessments (IA).
Compile/Analyze analytical validation data and test results.
Assure systems/processes consistently result in products or processes that meet established specifications and quality standards.

Education and Experience:
BS in Engineering (Mechanical, Electrical or Chemical)
At least 5 years of experience in the Pharmaceutical or Medical Devices Industry

Skills:
Excellent verbal communication and technical writing skills on both: English and Spanish.
Proficient in Microsoft Word, Excel and Power Point.
Ability to plan and manage own work.

Job Types: Full-time, Temporary

Salary: $20.00 to $25.00 /hour