Equipment Engineer

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.

• 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.