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Maintenance Calibration Technician III

Employer
Resilience
Location
Alachua, FL
Start date
Jun 20, 2024

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Discipline
Quality, Quality Assurance
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary & Role

The Calibration Technician III leads the Calibration team and performs routine calibration, maintenance, testing, troubleshooting, and repair on a variety of equipment, instrumentation throughout the facility, and analytical equipment that are typical in the Biomanufacturing industry.

Job Responsibilities

  • Organize, plan, execute and lead the activities of the site calibration function by providing technical, quality, compliance and safety leadership to calibration, preventive maintenance, and re-qualification related tasks.
  • Lead calibration, pressure balancing, and recertification of biosafety cabinets, laminar flow hoods, HEPA filters, and perform static and dynamic air flow visualization studies of aseptic processes and clean room facilities.
  • Generate Master Calibration documents, perform criticality assessments, and enroll devices, equipment and systems in CMMS. Add or remove equipment from CMMS as need to match business and project needs.
  • Generate and present calibration metrics on a periodic basis for review by site and corporate governance.
  • Apply knowledge of measurement science, mathematics, physics, and electronics to calibrate inspection, measurement, and test equipment (IM&TE) in the electrical, dimensional, optical, physical, mechanical, environmental, and/or chemical disciplines to ensure measurement accuracy.
  • Identify and utilize appropriate measurement procedures.
  • Perform corrective actions to address identified measurement problems.
  • Adapt equipment, standards, and procedures to accomplish unique measurements. Maintain calibration standards. Perform laboratory and/or departmental housekeeping.
  • Perform routine maintenance, troubleshooting, and repair on a variety of circuits, components, equipment and instrumentation for laboratory, manufacturing, and Facilities Utilities Systems Equipment (FUSE).
  • Set up, documentation and record entry in the Computerized Maintenance and calibration Management System, (CMMS/CCMS) such as ProCal and Maximo.
  • Uses test and diagnostic equipment to perform checks.
  • Performs electrical or mechanical troubleshooting to determine problems in non-functioning mechanical/electro-mechanical Lab, manufacturing and FUSE systems and equipment.
  • Dismantles, adjusts, repairs and assembles equipment according to layout plans, blueprints, operating or repair manuals, rough sketches or drawings; may perform equipment modifications as directed by engineers.
  • Specify and request purchase of components. Analyze results and may develop test specifications and Standard Operating Procedures (SOPs). Maintain all logs and required documentation.
  • Maintains spare parts inventory.
  • May prepare technical reports with recommendations for solutions to technical problems.

Minimum Job Qualifications

  • A trade certificate in electronics, instrumentation, calibration, mechatronics, or related field
  • Extensive calibration work experience in Pharma, BioPharma, medical device, or process industry
  • Experience working in a regulated industry in a calibration, metrology, or maintenance role
  • Ability to read, interpret, and follow SOPs, drawings, technical manuals, and specifications
  • Ability to author SOPs, work instructions, lists, spreadsheets etc.
  • Ability and willingness to learn and adapt skillsets to meet changing need of various equipment and process systems
  • Working knowledge on CMMS such as ProCal, Maximo

Preferred Job Qualifications

  • High School Diploma/GED Equivalent
  • Higher education (e.g.: Bachelor’s degree) in a related file of engineering (Instrumentation, Electrical, Process, etc.) is preferred.
  • Supervisory or Lead role experience in calibration or metrology or maintenance
  • Expertise migrating from one CMMS (e.g.: ProCal) to another (e.g.: Maximo)
  • Experience developing Master calibration documents and performing criticality assessment on large infra structure projects/processes
  • Experience leading and documenting failed calibrations and out of tolerance and related quality investigations, root cause analysis, and deviation and CAPA
  • Technical expertise in upstream / downstream process equipment, critical utility systems, clean room systems, and analytical and test equipment
  • Knowledge of regulatory compliance in pharmaceutical development
  • Ability work with internal and external partners on a fast pace
  • Strong leadership, communication, and organization skills is beneficial to this role
  • Ability to perform well under pressure and tight timelines
  • Knowledge of cGMP compliance related to bioprocess drug substance manufacturing

Role and Site-Specific Requirements

  • This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
  • Visual acuity such as: working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
  • Participation in an occupational health program (which can include medical assessment, surveillance, vaccination, and testing)
  • Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.)
  • Exposure to the following:
    • Moving mechanical parts, electrical current, working on high places, exposure to high heat or exposure to chemicals.
    • Handling, managing, disposing hazardous and non-hazardous waste (which can include: chemicals, universal and e-wastes, oil, aqueous wastewater, etc.), inclusive of exposure to bloodborne pathogens
    • Working in BSL-2/3 laboratories & production rooms, waste holding areas, or other facilities where biological hazards and hazardous chemicals may be stored or handled.
    • Conditions that affect the respiratory system or the skin: fumes, odors, dust, mists, gases, or poor ventilation.
    • Close quarters, narrow passageways, crawl spaces, shafts, manholes, small enclosed rooms, small sewage and line pipes.
    • Use of personal protective equipment (which can include respirators, Personal Air Purifying Respirators (PAPR), gowns, gloves, face protection, other barrier equipment, etc.
    • Noise exposure of over 85 decibels (enough noise to shout to be heard above ambient noise level).

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, disability status, physical or mental disability, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $24.00 - $36.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

Company

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development. For more information, visit www.Resilience.com and follow us on Twitter @IncResilience 

Company info
Website
Location
9310 Athena Circles
La Jolla
CA
92037
United States

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