Sr Engineer

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, is a leading services supplier providing solutions for various industries. They are seeking a Senior Engineer to independently lead process optimization and troubleshooting efforts, applying advanced engineering principles in a highly regulated environment.

Responsibilities:

• Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
• Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects
• Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity

Requirements:

• Engineer with years of experience, preferably in aseptic processing environments, including Fill/Finish operations such as vial and syringe filling lines
• Experience in characterization activities and performance qualification (PQ) for New Product Introductions (NPI)
• Minimum of 4 years of experience in direct pharmaceutical, medical device or biotechnology industries
• Experience in direct process / manufacturing areas
• Must be fully bilingual (English / Spanish) with excellent oral skills
• Must be proficient using MS Windows and Microsoft Office applications
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance
• Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT)
• Available to work extended hours, possibility of weekends and holidays
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate
• Ability to interpret and apply GLPs and GMPs
• Ability to apply engineering science to production
• Able to develop solutions to routine technical problems of limited scope
• Comprehensive understanding of validation protocol execution requirements
• Mechanical or Chemical Engineering