Calibration Technician II

KBI Biopharma; North Carolina; On-site; USD 60,000 - 80,000; Full time

Job summary

KBI Biopharma in North Carolina is seeking a Calibration Technician to join a GMP manufacturing team. You will calibrate instrumentation including temperature, RH, flow, pH, pressure, and weighing systems in controlled cleanroom environments, collaborating with QA, operations and engineering.

Qualifications include a two-year degree in engineering or life sciences, 3–6 years in a cGMP setting, and proficiency with SOPs and CMMS.

Qualifications

• Two-year degree in Engineering or Life Sciences required.
• 3–6 years of applicable experience in a cGMP pharmaceutical environment.
• Strong understanding of Standard Operating Procedures (SOPs).
• Ability to read P&ID diagrams and electrical schematics.
• Familiarity with Deviations and CAPA processes.

Responsibilities

• Calibrate process equipment and instrumentation per SOPs and TDs; assist with deviations and CAPAs.
• Troubleshoot mechanical, electrical, pneumatic, or hydraulic systems with maintenance staff.
• Support on-call rotations and safety procedures in a cleanroom environment.
• Maintain accurate records in the CMMS and related documentation.

Skills

Calibration experience

CGMP environment

SOP understanding

P&ID reading

Electrical schematics

MS Word/Excel/Outlook

Education

Two-year degree in Engineering or Life Sciences

Tools

CMMS

Job description

Job Description

• The calibration technician works within a team environment that actively supports, participates, and embraces an empowered team culture including significant interaction with Quality Assurance, Manufacturing Operations, Engineering, and other support groups.
• Perform Calibration to instrumentation that includes but is not limited to Temperature, Relative Humidity (RH), Timers, Speed (RPM), Flow, pH, Conductivity, Pressure, Load Cell Weight Indicators, Balances, and measurement Standards within a GMP facility while performing work in controlled clean room environment(s).
• Knowledgeable of National Institute of Standards Technology (NIST) or equivalent and Secondary Standard Laboratories.
• Request calibration quotes from vendors and assist with on-site calibrations by calibration contractors.
• Must be able to evaluate instrument and equipment performance, complete calculations, and perform Reverse Traceability Reports.
• Support calibration and instrumentation for NPI’s (New Product Introduction), which includes but is not limited to evaluation of current and future instruments and their range(s) / tolerance(s) to meet process requirements.
• Assist with execution of Corrective Preventive Action (CAPA) plans.
• Must be able to provide “On-Call” response to support plant operations during off-hours as required.
• Adhere to all safety requirements and follow all safety procedures.
• Regular scheduled shift may consist of weekend and/or swing/grave shift coverage.

Responsibilities

• Perform calibration to process equipment and instrumentation as required by established guidelines and Standard Operating Procedures (SOP’s), Training Modules (TRN), and Technical Documents (TD). Ability to conduct troubleshooting by use of equipment manuals and drawings, identifying root cause, and assist in determining appropriate corrective actions for equipment failures. Generate and assist with resolving Deviations, CAPA’s to instrument and equipment.
• Assist and troubleshoot with maintenance personnel with general facility repairs not to exclude lighting, walls, floors, windows as well as troubleshoot equipment and systems, including mechanical, electrical, pneumatic, or hydraulic circuits (motors, pumps, compressors, boilers, chillers, and purified and domestic water systems).
• Perform repairs on associated equipment to calibrated loops (cords, transmitters, or probes).
• Provide “On-Call” response to support plant operations during off-hours as required.
• Adhere to all safety requirements and follow safe procedures, immediately notifying management or HSE when unsafe conditions or potential hazards are found; attend all required safety and health training requirements.

Requirements

• High School diploma and a two-year degree in Engineering, Life Sciences, other related technical field or equivalent military training with 3 - 6 years of applicable experience or the equivalent combination of education and experience.
• Prior experience in a cGMP pharmaceutical manufacturing environment preferred.
• Strong understanding of Standard Operating Procedures.
• Familiar working within Computerized Maintenance Management Systems to schedule and document work performed.
• Basic knowledge of 4-20 mA loops, low voltage signals, 120 VAC/DC.
• Knowledge of Deviations and CAPA’s.
• Knowledge of general OSHA safety requirements a plus.
• Knowledge of hand and power tools.Must be able to read P&ID’s and electrical schematics.
• Must be able to use Word, Excel and Outlook.

Additional Skills and Abilities

• Reasoning Ability: Demonstrated ability to apply logical thinking and sound judgment to assess situations and solve problems using new or existing information.
• Mathematical and Engineering Skills: Proficient in problem-solving with a strong understanding of mathematical concepts and the application of engineering principles.
• Physical Demands: Must be able to walk, lift, push, sit, stand, and climb as required by job tasks.
• Equipment Use: Experienced in the use of computers, telephones, plotters, copiers, and fax machines.

Working Conditions

Work may be performed in a variety of environments, including:

• Mechanical Spaces
• Clean Room Environments
• Confined Workspaces
• Participation in a Scheduled On-Call Rotation is required.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.