Technical Operations Specialist

1 week ago


San Diego, California, United States Manpower San Diego Full time
Job Summary

Manpower San Diego is seeking a highly skilled Equipment Maintenance Specialist to join our team. As an Equipment Maintenance Specialist, you will be responsible for ensuring the smooth operation of laboratory equipment, maintaining compliance with regulatory guidelines, and providing technical support to our team.

Key Responsibilities
  • Maintenance and Repair: Perform routine maintenance and repairs on laboratory equipment to ensure optimal performance and compliance with cGMP/GLP guidelines.
  • Technical Support: Provide technical assistance and troubleshooting to resolve equipment-related issues in a timely and efficient manner.
  • Documentation and Compliance: Maintain accurate records of equipment maintenance, repairs, and testing to ensure compliance with ISO 13485 and other regulatory requirements.
  • Integration and Automation: Collaborate with the operations team to integrate equipment maintenance with existing systems and scripts, and develop custom workflows to improve efficiency.
  • Validation and Verification: Develop and execute validation protocols for new and modified equipment, software, and instrument interfaces to ensure compliance with regulatory requirements.
  • Technical Writing: Author technical documents, including Standard Operating Procedures (SOPs), Validation Protocols, and Reports, to ensure clear communication of technical information.
  • Training and Development: Provide training and support to operators on the use of new equipment and processes, and develop training materials to ensure effective knowledge transfer.
  • Vendor Management: Serve as the primary point of contact for internal and external equipment providers, ensuring that all work performed by external contractors is completed and documented in accordance with our site quality systems.
Requirements
  • Experience: 2+ years of experience working on laboratory equipment, preferably in a clinically regulated environment.
  • Technical Skills: 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.
  • Automation Experience: Data automation scripting experience (R, Python, shell/batch) is a plus.


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