Summary: 

SMART PRECISE SOLUTIONS, Inc. is a project management and consulting provider with a full range of services to industrial, commercial, real estate, healthcare, and hospitality facilities. Since its foundation, the Company has had proven outstanding performance in project and construction management services. The company has been distinguished by its high capacity to manage small projects as well as large-scale projects. Confident that we can supply our clients with a truly integrated service that is designed to achieve higher quality standards at lower costs and at a fast-track pace designed to achieve a satisfactory project outcome. 

We are looking for a Process Validations Engineer eager to develop and maintain Validation Life Cycle requirements established, ensuring compliance to the applicable business and regulatory standards. Defines testing strategies and documents the performance and compliance of the validation program. 

The  Process Validation Engineer 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. Protocol development skills will include the ability to develop Installation, Operational, and Performance qualification documents. 

Responsibilities:

1. Develop Verification / Qualification deliverables including but not limited to requirement documents as: 

• Design Specifications (DS) 
• Functions Specifications (FS) 
• User Requirements Specifications (URS) 
• Factory Acceptance Tests, and Impact Assessments (IA). 
• Validation Master Plan (VMP) 
• Process Validation Protocols (IQ, OQ, PQ) 
• Manufacturing Standard Operating Procedures 
• Test Methods 
• Preventive Maintenance Procedures 

2. Development, documentation, and execution of different processes as: 

• Prepare and review completed and executed validation packages. 
• Compiling and analyzing validation data for submission for review and approval. 
• Lead resolution of deviations through technical knowledge. 
• Supporting validation studies, and manufacturing documentation review and approval. 
• Validations Activities. 
• Test Protocols, including identification and resolution of non-conformances / deviations. 
• Write validation plans and risk assessments related to specific projects and facilities. 

3. Tracking and managing change control activities for multiple concurrent projects. 

4. Maintain up-to-date knowledge of validation requirements, practices, and procedures. 

5. Facilitate the development of user requirement specifications and operational SOPs for equipment. 

6. Collaborate and participate in Technical Meetings. 

• a. Organizing, attending and participating in Stakeholder, Clients, Contractors, Suppliers / Vendors' meetings. 
• b. Document and track important actions and decisions from meetings through reporting. 

7. Assure systems/processes consistently results in products or processes that meet established specifications and quality standards. 

8. Other duties as assigned by his supervisor according to business priorities and as per Company project management structure guidelines. Which includes but is not limited to: 

• Coordinate Equipment Installations and Calibrations 
• SAP System Management 
• Develop and system trouting of Change Control and Change Request. 
• Challenge and red-Line Equipment Electrical Drawings. 
• Develop Equipment Quotation requests from external vendors. 
• Compile / Analyze analytical validation data and test results. 
• Edit Product Specifications 
• Train Manufacturing Personnel 

Skills Set Requirements: 

• You must be good at time management, organization, presentations, and communication. 
• Excellent writing skills. 
• Be a self-starter and be motivated to provide solid product quality and customer experience, possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific/technical discipline. 
• Well-developed knowledge of medical devices industry standards and requirements. 

Requirements: 

• Bachelor's degree in Mechanical, Electrical , Computer or Chemical Engineer. 
• At least 1-5 years of experience in Pharmaceuticals, Medical Devices, Biotechnology Industry. 
• Fully Bilingual in Spanish and English. 
• Experience: Pharmaceutical and Medical Devices Industries. 
• Proficient in MS Office 365 (Word, PowerPoint. Excel) 
• Licenses & Certifications: Engineer in Training License (EIT) required, Professional Engineer (PE) preferred. 

Smart Precise Solutions, LLC is an Equal Opportunity Employer. 

Smart Precise Solutions, LLC and all its divisions, subsidiaries, and affiliates hereby reaffirm the Company policy of non-discrimination in all aspects of the business.