Responsibilities

Job Description Summary:

We are seeking a skilled and detail-oriented Calibration Engineer to join our team. The Calibration Engineer will be responsible for ensuring that all laboratory and manufacturing equipment used in our biopharma operations is accurately calibrated and meets regulatory and industry standards. This role is critical in maintaining compliance with GMP, FDA, and ISO requirements while supporting process efficiency and product quality.

Job Responsibilities

• Perform calibration, validation, and maintenance of laboratory and production equipment, including but not limited to pH meters, balances, pressure sensors, temperature controllers, and analytical instruments.
• Develop and execute calibration protocols and procedures in compliance with GMP, FDA, and ISO 17025 standards.
• Troubleshoot and resolve calibration-related issues to ensure equipment operates within specified tolerances.
• Maintain detailed and accurate calibration records, certificates, and documentation for audit readiness.
• Coordinate with internal teams and external vendors to schedule and conduct equipment calibrations and maintenance.
• Support investigations related to equipment performance, deviations, and non-conformances.
• Recommend process improvements and implement best practices to enhance equipment reliability and compliance.
• Ensure adherence to safety procedures and company policies during all calibration activities.
• Stay up to date with industry regulations and technological advancements in calibration and metrology.
• Maintain training and compliance in areas of health and safety, security, environmental and operational aspects of daily activities in the working environment.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Critical Skills:

• Ability to work independently and as part of a team in a regulated environment.
• Excellent analytical, problem-solving, and communication skills.

• Attention to detail and process oriented

Basic Qualifications:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Instrumentation) or a related technical field.  OR

• Experience in calibration or validation

Preferred Qualifications:

• Training or experience in ISO17025 or equivalent
  Training in calibration and measurement equipment
  Certification in calibration (e.g., ASQ Certified Calibration Technician) is a plus.
  

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory. 
• Job pace may be fast and job completion demands may be high. 
• Must be able to remain in a stationary position more than 25% of the time 
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.   
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds). 
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.   
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer. 
• Employee may be required to handle hazardous waste according to local, state, and federal regulations.  Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste. 
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.