Equipment Engineer I

Job Description Responsibilities Maintain lab equipment in good working order following cGMP/GLP guidelines. Respond to equipment related issues in a timely and intelligent manner. Document all equipment related activities to assure compliance with ISO 13485. Integrate the operations and oversight of equipment with existing Camstar system and custom equipment management scripts. Code, test and implement custom workflows. Create and execute validation protocols for all new and modified equipment, software and instrument interfaces. Author technical documents including Standard Operating Procedures (SOPs), Validation Protocols and Reports. Provide training materials and assist with training of operators on the use of new equipment and processes. Serve as the primary point of contact for internal and external equipment providers. Ensure that all work performed by external contractors is completed and documented in accordance with the site quality system. Requirements BS in Engineering. Experience working on laboratory equipment preferred. Experience working in a clinically regulated environment is highly desirable. Excellent technical troubleshooting skills, mechanical aptitude, and communication skills, including experience authoring verification/validation protocols, standard operating procedures/work instructions, CAPA investigations and Non‑Conformance records. Data automation scripting experience (R, Python, shell/batch) is a plus. #J-18808-Ljbffr 6AM City, LLC