Location: San Diego, CA
- Write and execute equipment calibration procedures that are effective, efficient and in alignment with industry best practices.
- Establish calibration specifications that account for process tolerances and equipment manufacturer’s tolerances.
- Review calibration certificates generated by contractors for accuracy, completeness and technical elements.
- Maintain Metrology standards in a controlled and calibrated state.
- Write and execute qualification protocols for selected manufacturing and laboratory equipment and utilities.
- Assess the return on investment associated with bringing selected contracted calibrations and qualifications in-house.
- 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.
- Install, maintain, repair and troubleshoot manufacturing, facilities and laboratory equipment, as needed.
- Assist in the equipment selection process and co-author equipment procedures, as needed.
- Follow all safety procedures, policies and precautions.
- Other duties as assigned.
- Metrology experience in a GMP pharmaceutical, biotechnology and/or contract manufacturing environment.
- Ability to critically assess complex issues related to equipment troubleshooting, OOT conditions, testing strategies, etc.
- Ability to document work in a clear and concise manner, in accordance with defined Good Documentation Practices.
- Candidate must have a general understanding of risk-based system validation and the ability to develop phase-appropriate testing strategies.
- 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.
- Familiarity with FDA, EudraLex and ISO regulations and guidance documents pertaining to sterile product manufacturing is strongly preferred.
- 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.
- Associate’s Degree with 8+ years of Metrology Experience or Bachelor’s Degree with 5+ years of Metrology 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 occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus.