- February 25, 2021
- Automation, Engineering, Greater San Diego Area, CA, Pharmaceuticals
0819 Utility Automation Commissioning and Qualification Engineer PART-TIME
Summary:
Provides commissioning and qualification/validation support for site utility automation systems, including support of system lifecycle and project documentation.
Key Responsibilities:
Generate qualification/validation protocols and related lifecycle documentation.
Coordinate and execute test protocols and resolve deviations. Support related activities.
Route documentation for approval, including expedited routing as required.
Generate, execute, and route for approval of other documents to support startup, operation, and maintenance of systems.
Support system troubleshooting in association with commissioning/qualification activities.
Collaborate with key stakeholders and projects related to commissioning and qualification/validation activities.
Maintain change management for related changes associated with commissioning and qualification of utility automation infrastructure.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Knowledge, Skills, and Abilities:
Experience with commissioning & validation of environmental chamber temperature monitoring.
Startup and commissioning experience with Siemens Apogee / Insight BMS and Rockwell Automation platforms.
Hands-on ability to troubleshoot instruments, controllers, and other associated PLC/BMS equipment.
Practical knowledge and ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
Excellent communication, writing, organization, and time management skills.
Able to work within confined spaces and/or heights exceeding 8 feet for extended periods of time.
Minimum 5 years automation commissioning and qualification experience, including protocol generation, preferably within a GMP environment.
Education:
Bachelor’s degree in Automation /Engineering (Mechanical, Chemical or Electrical) or equivalent experience.