Validation \/ Calibration Technician III

Location
San Diego, California, United States
Posted
Nov 11, 2020
Ref
oR6ZdfwT
Hotbed
Biotech Beach
Required Education
High School or equivalent
Position Type
Full time
SUMMARY Perform and appropriately document the calibration, qualification, troubleshooting, and repair of a variety of analytical, manufacturing, and facility equipment. Assist in the development of in-house qualification, calibration and maintenance procedures; and provide knowledgeable customer service to equipment owners.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
  • Adhere to Good Manufacturing Practices (GMPs), including adherence to all company SOPs and documentation standards
  • Maintain clear, concise, and compliant records of all work performed for the purpose of documenting the control of all equipment and utilities
  • Perform routine calibrations and requalifications as required, as well as non-routine calibrations and requalifications as business needs dictate
  • Review calibration documents for accuracy and completeness
  • Execute and report temperature mapping studies of controlled storage equipment
  • Write and execute equipment qualification protocols for laboratory, manufacturing, and facility equipment; and report protocol execution results
  • Clearly communicate calibration/requalification schedules and equipment status with Equipment Owners
  • Maintain all metrology standards in working condition and ensure that they are used within their calibration intervals
  • Schedule and escort contract calibration and validation providers, and review their documents for accuracy
  • Assist in gathering and shipping equipment that requires off-site calibration.
  • Write and/or review calibration procedures, calibration specifications and calibration worksheets.
  • Provide guidance to Equipment Owners regarding the selection and maintenance of equipment.
  • Move and install equipment, when required
  • Perform both scheduled and unscheduled maintenance on laboratory, facility, and manufacturing equipment, when required
  • Assist in calibration and validation document management, including data entry and filing


SUPERVISORY RESPONSIBILITIES
This job has no supervisory responsibilities.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE
Generally requires a high school degree, a Bachelors of Science degree in a scientific field is preferred, with 4-6 years of related experience. Knowledge and understanding of quality assurance in a laboratory or manufacturing environment, as well as laboratory controls and safety is required. Experience working in a FDA GXP and/or QSR regulated environment is strongly preferred. Computer skills competency including Excel, Word and PowerPoint programs is required. Experience operating, calibrating, qualifying, and maintaining laboratory and manufacturing equipment is required.

LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff and groups of managers. Ability to develop and maintain effective working relationships with all levels of management.

MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where general standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Ability to understand and comply with all applicable laboratory regulated guidelines.

CERTIFICATES, LICENSES, REGISTRATIONS
None required.

PHYSICAL DEMANDS
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 is regularly required to sit and talk or hear. The employee frequently is required to use hands to manipulate equipment, materials, and/or documents. The employee is often required to stand for periods of time, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing 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 is occasionally exposed to moving mechanical parts, fumes or airborne particles, potentially infectious bodily fluids, toxic or caustic chemicals, and extreme cold.

The noise level in the work environment is moderate.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.