Calibration Engineer

Responsibilities

1. Oversee the installation of instruments and sensors, ensuring correct placement and connection to control and data acquisition systems.
2. Develop a calibration plan outlining procedures and frequency for all relevant instruments and systems.
3. Create a comprehensive instrument index, categorizing instruments by criticality, process tolerance, calibration, and range.
4. Develop and execute calibration procedures per industry standards and manufacturer guidelines.
5. Adjust, assess, and verify instrument accuracy.
6. Establish and maintain an inventory of all instruments and sensors, focusing on those critical to the vaccine manufacturing process.
7. Perform routine calibrations of critical instruments and sensors as per the established schedule (e.g., temperature, pressure, flow).
8. Maintain calibration records, including pre- and post-calibration measurements and revisions.
9. Plan and execute maintenance activities to prevent instrument drift or failure (e.g., cleaning, sensor replacement).
10. Analyze calibration data over time to identify trends or deviations for proactive maintenance.
11. Implement actions to maintain accuracy and reliability of instruments, ensuring compliance with regulatory standards.
12. Address emergency calibration needs promptly for any critical instrument deviations.
13. Manage calibration-related change control processes, documenting and validating changes to instruments or procedures.
14. Manage spare parts inventory for instruments and sensors, ensuring availability of replacement components.
15. Provide training to plant personnel on proper use and maintenance of instruments and sensors.
16. Prepare for audits through self-assessments and mock audits; serve as a subject matter expert during audits.
17. Oversee internal calibration technicians and external service providers.
18. Provide leadership, guidance, and training to ensure effective and efficient calibrations.
19. Assign calibration tasks based on workload, priority, and skill sets.

Knowledge, Skills & Competencies

• Knowledge of regulatory requirements (FDA, EMA, HSA regulations, cGMP).
• Familiarity with relevant software tools and programming languages.
• Proficiency in instrumentation systems (design, installation, testing, troubleshooting).
• Excellent verbal and written communication skills for internal and external interactions.
• Strong analytical and problem-solving skills for diagnosing technical issues.
• Familiarity with industry codes, standards, and safety regulations.
• Project ownership and decision-making skills.
• Project scheduling and reporting skills.
• Ability to lead contingent staff and external resources (vendors and contractors).
• Team player committed to achieving common goals.

Qualifications / Requirements

• Related Engineering Degree from an accredited technical institution.
• Minimum of 10+ years of experience in instrument calibration and maintenance, preferably in a pharmaceutical or vaccine manufacturing environment.