What are the responsibilities and job description for the Laboratory Engineering Support Technician position at Medix™?
Essential Functions:
- Assist in executing validation protocols.
- Provide hands-on support for diagnostics and troubleshooting.
- Contribute to the design and implementation of engineering solutions to address operational issues, drive continuous improvement, and introduce new technology, ensuring compliance with standards and cGMP regulatory requirements.
- Offer laboratory engineering support for capital projects, managing a dynamic workload based on site priorities.
- Review technical equipment manuals and recommend routine maintenance, calibration, spare parts, etc.
- Serve as a subject matter expert in developing engineering and validation documents, including User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for both new and existing analytical/process equipment systems.
- Train coworkers and peers on analytical equipment functionality, troubleshooting, and diagnostic techniques to enhance organizational capability.
- Develop and update laboratory engineering SOPs.
- Support investigations to identify root causes and implement corrective and preventive actions to prevent recurrence.
- Collaborate with key site functions (Manufacturing, Analytical and Process Development, Technical Operations, Engineering, and Quality) to meet site goals and objectives.
- Lead tasks with minimal guidance and supervision.
- Interface with IT to ensure GMP and GLP-compliant integrations.
- Assist with system, specification development, and design preparation.
- Support data integrity initiatives.
- Perform all duties in compliance with applicable laws, regulations, and industry codes, maintaining an ethical approach at all times.
- Perform other duties as assigned.
Preferred Skills & Abilities:
- Familiarity with GAMP and other System Development Life Cycle (SDLC) methodologies.
- Knowledge of 21 CFR Part 11 regulations.
- Experience with change control and CAPA processes.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).
- Ability to work in a fast-paced, state-of-the-art, research, and customized manufacturing environment.
- Experience with PC imaging design and testing.
- Familiarity with software installation and testing processes.
Salary : $20 - $23
