Location: San Diego, CA
- Follow and execute equipment calibration procedures that are effective, efficient and in alignment with industry best practices.
- Install, maintain, repair and troubleshoot manufacturing, facilities and laboratory equipment.
- Review calibration certificates generated by contractors for accuracy, completeness and technical elements.
- Utilize an equipment database to track equipment, run reports and enter executed calibrations, maintenance and qualifications.
- Assess qualified equipment for adherence to qualified state and/or requalification needs, including the use of trend data from sources such as a building management system software application.
- Assist in the equipment selection process and co-author equipment procedures, as needed.
- Follow all safety procedures, policies and precautions.
- Other duties as assigned.
- Calibration/Metrology experience in a GMP or ISO manufacturing environment is preferred.
- Experience working with or on biologics manufacturing equipment preferred.
- Ability to critically assess complex issues related to equipment troubleshooting, OOT conditions, testing strategies, etc.
- Experience working with a CMMS. Qualer or Blue Mountain experience preferred.
- Ability to document work in a clear and concise manner, in accordance with defined Good Documentation Practices.
- Proficiency in, MS Word, MS Excel and MS PowerPoint, as well as experience with equipment/asset management databases and building management systems is strongly preferred.
- Additional key skills that are needed to excel in this position include attention to detail, ability to multi-task, follow through, and interpersonal skills that facilitate cross-functional collaboration.
- PMEL, TMDE, ITMD, or GCAM training with 3 to 8 years of direct experience.
- Associate degree with 3 to 8 years of technical experience.
- Bachelor’s degree with 3 to 5 years of technical experience.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee may be required to sit for extended periods of time in front of a computer monitor. The employee is frequently required to use hands to manipulate, handle or feel. The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear. The employee must regularly lift and/or move up to 60 pounds. Specific vision abilities required by this job include color vision, close vision, distance vision, peripheral vision, depth perception and ability to focus.