Validation, Calibration, And Preventative Maintenance Technician I (Pt)

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 Ito our Facilities Team.The VCPM Technician I is responsible for maintaining the validation, calibration, and Preventative Maintenance programs under ISO 13485, 21CFR Part 820, as well as other external regulations.

Core Responsibilities Include:

• Assists in the facility team with equipment validation program.
• Coordinating with offsite service providers and on-site staff for validation of equipment.
• Execution of validation protocols.
• Assists in the facility team with the calibration program.
• Coordinating with offsite service providers and on-site staff for calibration of equipment.
• Execution of calibration protocols and documenting the calibration of equipment.
• Execution, and closure of Calibration work orders.
• Closure of Calibration Work orders. Verification that the responsible calibration provider has appropriately completed calibration activities is required to close work order.
• Assists in the Preventative Maintenance (PM) program.
• Coordinating with offsite service providers and on-site staff for PM or repair of equipment.
• Execution, and closure of Preventative Maintenance and repair work orders.
• Maintenance of equipment maintenance procedures.
• Assists in managing the equipment asset program used for both the PM and calibration.
• Assists in the general facility department needs.
• Ensuring new equipment is purchased per standard operating procedures and that upon receipt are held until all necessary incoming equipment specifications are met.
• Tagging equipment out of service when necessary and returning them into service when appropriate.
• Monitoring of critical equipment to ensure materials and processes meet defined specifications.
• Proficient use of electronic documentation systems such as QCBD and Vaisala to document validations, calibrations, and PM.
• Assists in the creation, implementation, maintenance, and improvements to the facility through Standard Operating Procedures (SOP), reports, and training.
• Trains personnel in SOPs and facilities related software systems as needed.
• Serves as the technical lead; provides guidance and direction to Preventative Maintenance Technicians.

You Bring:

High School diploma required and typically, 0-2 years applicable experience. Some college coursework and/or relevant certification(s) preferred. Bachelor’s Degree in a related field of study highly preferred. Equivalent combination of education and experience will be considered.

• Working knowledge of PCR and molecular biology is beneficial.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel, and PowerPoint) and the ability to learn new software programs.
• Exposure to, and/or experience with, the following is beneficial: Industry experience in cGMP environment that includes aspects of validation and calibration. Experience with aseptic techniques. Able to use Adobe Acrobat and Bluebeam for artwork and graphics in documents. Working knowledge of an ERP systems.
• 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.
• The expected pay scale is 20.00 to 24.00 per hour.

Invivoscribe is an Equal Opportunity Employer.

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

Job Type: Part-time

Pay: $20.00 - $24.00 per hour

Expected hours: 25 – 30 per week

Schedule:

• 4 hour shift
• 8 hour shift
• Monday to Friday

Work Location: In person