Job description

Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services. We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started!

We are looking to add a Validation Calibration and Preventative Maintenance Technician I to our Facilities Team. The Validation and Preventative Maintenance Technician I (VPMT I) is responsible for maintaining the equipment validation, calibration and preventative maintenance programs under ISO 13485 and 21 CFR Part 820.

Core Responsibilities Include:

• Assists in the facility and equipment validation program.
• Coordinates with offsite service providers and on-site staff for validation of equipment.
• Execution and maintenance of validation protocols. Writes validation reports based on the results of these protocols.
• Assists in the calibration program.
• Coordinates with offsite service providers and on-site staff for calibration of equipment.
• Closure of Calibration Work orders. Verifies that the responsible calibration provider has appropriately completed calibration activities is required to close the work order.
• Assists in the Preventative Maintenance (PM) program.
• Assists with coordinating with off-site service providers and on-site staff for PM or repair of equipment.
• Executes and closes preventative maintenance and repair work orders.
• Implements and maintains equipment maintenance procedures.
• Assists with managing the equipment asset program used for both the PM and calibration.
• Ensures new equipment has been purchased per Standard Operating Procedures (SOPs) and that upon receipt are held until all necessary incoming equipment specifications are met.
• Tags equipment out of service when necessary and returns them into service when appropriate.
• Monitors critical equipment to ensure materials and processes meet defined specifications (Vaisala and CheckPoint).
• Proficient use of electronic documentation systems such as QCBD, Vaisala and CheckPoint to document validations, calibrations and PM.
• Assists in the creation, implementation, maintenance and improvements to the facility through SOPs, reports and training.
• Trains personnel in SOPs and facilities-related software systems as needed.

You Bring:

• Knowledge and skills normally acquired through the successful completion of a Bachelor’s degree. A Bachelor’s of Science degree in a scientific discipline is beneficial.
• Experience in a regulated industry or equivalent combination of education and experience is beneficial.
• Direct working knowledge of ERP systems is beneficial.
• Evidence of Covid-19 vaccination

We Bring:

• A beautiful modern facility centrally located in San Diego County, with many jobs conducive to a hybrid work from home arrangement.
• A safe, fully-vaccinated, work environment.
• A diverse and inclusive work environment where you will learn, grow, and make new friends.
• A well-stocked breakroom with hot and cold beverages, snacks, refrigerator and pantry items to get you through the day.
• Competitive salaries and bonus program, incentive stock options, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays.

Invivoscribe is an Equal Opportunity Employer.

Evidence of COVID-19 vaccination will be required as a condition of employment.

Job Type: Full-time

Pay: $20.00 - $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

COVID-19 considerations:
Evidence of COVID-19 vaccination will be required as a condition of employment.

Work Location: One location

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