Job Description

The Calibration Technician is responsible for performing routine and non-routine calibration of instruments and equipment used at the Civica Petersburg sterile injectable pharmaceutical manufacturing facility. This role ensures that all critical systems operate within specified tolerances and comply with regulatory standards, including FDA, EU, GMP, and ISO guidelines.

Essential Duties and Responsibilities:

·         Perform scheduled and unscheduled calibrations on a wide range of instruments, including pressure gauges, temperature sensors, balances, pH meters, and cleanroom monitoring devices, among others, and document properly in the CMMS.

·         Maintain accurate and complete calibration records in compliance with cGMP and internal quality standards.

·         Troubleshoot and resolve calibration issues, including out-of-tolerance (OOT) conditions, and escalate as necessary.

·         Support investigations, deviations, CAPA, and change control processes related to calibration activities.

·         Ensure calibration standards and reference instruments are maintained and traceable to national/international standards.

·         Assist in the preparation for internal and external audits by providing calibration documentation and technical support.

·         Collaborate with Quality Assurance, Maintenance, and Production teams to ensure equipment readiness and compliance.

·         Follow and contribute to the development and revision of Standard Operating Procedures (SOPs) related to calibration.

·         Maintain calibration schedules and ensure timely execution to prevent overdue equipment.

·         Adhere to all safety, environmental, and contamination control procedures in sterile and cleanroom environments.

·         Assist with calibration SOP revisions.

·         Work with data acquisition and validation equipment (e.g., process control equipment/controllers, Dataloggers, DC Analog/Signal Conditioners, and transducers).

·         Troubleshoot, inspect, and repair test and measurement equipment in support of new projects.

·         Provide on-site calibration support for equipment that is either too sensitive to move or is too large and not feasible to relocate.

·         Work overtime when necessary to support high-priority requests or meet project goals.

·         Perform preventative maintenance tasks related to calibration activities.

·         Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.

·         Able to work safely in an environment containing hazardous chemicals, high and low temperature liquids, high-pressure liquids and gases, steam, and moving machinery.

·         Able to check, respond to, and troubleshoot Equipment Monitoring System (EMS) & Building Management Systems (BMS) issues and alarms.

Basic Qualifications and Capabilities:

·         Associate's degree or technical certification in Instrumentation, Electronics, Engineering Technology, or related field.

·         Minimum of 2+ years of calibration experience in a GMP-regulated pharmaceutical or biotech environment, preferably sterile injectables.

·         Understanding of calibration principles, metrology, and regulatory compliance (FDA, EU GMP, ISO 17025).

·         Excellent documentation and communication skills.

·         Proficiency with calibration management systems (e.g., CMMS, Blue Mountain, Maximo)

·         Ability & experience reading schematics, wiring diagrams & other technical documents.

Preferred Qualifications:

·         Exceptional organizational and teamwork skills are required to be successful in this dynamic environment with changing priorities.

·         Experience with regulatory inspections.

·         Experience with continuous improvement/lean tools such as Six Sigma, 5-S, Lean Manufacturing, Transactional Lean, etc.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodation may be made to enable individuals with disabilities to perform the functions. Work performed in cleanroom and controlled environments requiring gowning and adherence to aseptic techniques.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand, walk, sit, crouch, and reach with hands and arms and access areas with restricted space. The employee must occasionally lift and/or move up to 20 kg. Specific vision abilities required for this position include close and distance vision and the ability to adjust focus. The noise level in the work environment is usually low to moderate. 

The company is an Equal Opportunity Employer, a drug-free workplace, and complies with ADA regulations as applicable.