Equipment Engineer 1
San Diego, CA
6 month contract
$30-37/hr
We are looking for someone who would be willing to be able to spend time on the manufacturing floor/willing to be hands on with the tools we support to best support the manufacturing team.
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:
- 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.
- Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position.
- Changes to individual responsibilities may occur due to business needs.
- B.S. in Engineering required
