Saugus, Massachusetts, United States
Mostly working as a Project / Packaging/ Manufacturing / Serialization / Biotechnology / CQV / QAV/ Validation Engineer in a wide variety of projects and applications. Particularly interested in Biotechnology Cell Harvesting, Processing equipment, Packaging, or any Manufacturing line expansions that might require the use of someone with strong exposure to Validation or Operations in the Pharmaceutical/ Biological/ Medical Device Industry. In addition, acting as a collaborator conducting CAPAs, Supplier & Co-Manufacturer Audits, Quality Systems Reviews, and SOPs development. Also specializing in Validation/ Commissioning/ Equipment Qualification for manufacturing, facilities, utilities, and also on Packaging equipment. Specialties: - Experience with Biotechnology process equipment (Bioreactors, SIP of tanks and skids, Incubators and Bio Safety cabinets. Performing Temperature Mapping, Issuing Change Controls, P&ID Redline and performing Walk downs of "As Built" Drawings. -Experience with Solid Dosage Manufacturing Operations: Lifting & Handling, Storage & Transfer, Dosing & Weighing, Blending & Mixing, Granulation & Coating. - Experience with the qualification and validation of the following equipment’s: PK Blender (Blending Process), Courtoy, Fette, Korsh and Manesty (Compression Process) and Ackley Brander. - Experience writing SOP’s, GAP assessment, Risk Assessment, Functional Requirements. - Experience in all aspects of systems testing, writing test plans, test scenarios and test cases; conducting system testing [regression, integration, and stress analysis] and expertise in Statistical Process Control (SPC). - Experience reviewing and evaluating System Life Cycle documentation, Computer Validation Protocols, and their applicable SOP’s. - Experience in Packaging Equipment Validation (Bottle Lines, Blister Lines, and semi-solid) - Recognized for ability to face challenges head-on and execute sound decisions in the face of adversity. - Experience with Optel Vision Serialization Systems ( Track & Trace, Bottle Tracker, Carton Tracker, Virtual Bundle and Line Master) Validation. - Working with EMPQs for manufacturing Suites, IOQ's and PQ's for Biotech manufacturing equipment. - FDA Regulations, ISO 13485, ISO 14971, and ISO 14644 1.
Performing CQV Activities with Biotechnology related equipment.
Performing CQV for Biotechnology and Process related equipment.
-Providing CQV and Validation support to the Minneapolis Site for the Oncology & Biologic BU division for Takeda Pharmaceuticals. -Preparing, reviewing and maintaining system Validation documents, including compliance documentation, such as protocols using change control systems and engineering documentation. -Active participant in the development of Validation deliverables such as; Functional and User Requirements Specification, Software and Hardware Design Specifications, Validation Master Plans, Installation and Operational Qualification protocols, Requirements Traceability Matrix and Validation Reports accordingly. -Working with the workflow of Validation Deliverables as per System Development Life Cycle (SDLC) through an Electronic Document Management System ( e.g. LEADs).