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Equipment Specialist

2 months ago

California, United States Planet Pharma Full time
Equipment Engineer 1

We are seeking a highly skilled Equipment Engineer 1 to play a critical role in ensuring the smooth operation of our manufacturing floor at Planet Pharma.

About the Role
  • Maintain laboratory equipment in good working order, adhering to cGMP/GLP guidelines and ensuring compliance with ISO 13485.
  • Respond to equipment-related issues in a timely and intelligent manner, documenting all activities to ensure seamless integration with our existing camstar system and custom equipment management scripts.
  • Integrate equipment operations with our existing camstar system and custom equipment management scripts, testing and implementing custom workflows to optimize manufacturing efficiency.
  • Create and execute validation protocols for new and modified equipment software and instrument interfaces, ensuring accuracy and reliability.
  • Author technical documents, including Standard Operating Procedures (SOPs), Validation Protocols, and Reports, to maintain a high level of documentation and compliance.
  • Develop training materials and assist with training operators on new equipment and processes, ensuring a smooth transition and minimizing downtime.
  • Serve as the primary point of contact for internal and external equipment providers, ensuring effective communication and collaboration.
  • Ensure that all work performed by external contractors is completed and documented in accordance with our site quality system, maintaining a high level of quality and compliance.
Requirements
  • Experience working on laboratory equipment is preferred, with a strong understanding of cGMP/GLP guidelines and ISO 13485.
  • Experience in a clinically regulated environment is highly desirable, with a strong understanding of regulatory requirements.
  • Excellent technical troubleshooting skills, mechanical aptitude, and communication skills, including experience authoring verification/validation protocols, SOPs, CAPA investigations, and Non-Conformance records.
  • Data automation scripting experience, with proficiency in R, Python, shell, or batch scripting.
  • B.S. in Engineering is required, with a strong foundation in engineering principles and practices.