Engineer II, Calibration
Vaccines M&S is preparing its future through an ambitious program named Evolutive Facility. The EVF Project is at the cornerstone of Sanofi strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.
She or he holds the responsible for establishing a calibration program for a new vaccine manufacturing facility to ensure the accuracy, reliability, and compliance of all instruments used in the process of manufacturing. Manage all calibration activities during the plant operation phase, include routine calibration, troubleshooting, and maintaining a wide range of instruments to support the production of high-quality vaccines and align with Industry and Digital 4.0 initiatives.
The Calibration Engineer will report to Senior E&I Lead Engineer.
Roles & Responsibilities
Installation and Start-up
- Instrument Installation: Oversee the installation of instruments and sensors, ensuring they are correctly placed and connected to the control and data acquisition systems.
- Calibration Plan Development: Develop a calibration plan that outlines the procedures and frequency of calibration for all relevant instruments and systems. This plan should consider industry standards and project-specific requirements. Create a comprehensive Instrument index, Categorize, and identify instruments criticality, Process tolerance, calibration, and instrument range for all the instruments.
- Calibration Procedures: Develop and execute calibration procedures for each instrument and system, following industry standards and manufacturer guidelines. This includes adjusting, assessment and verifying instrument accuracy.
- Instrument Inventory: Establish an inventory of all instruments and sensors in the facility, including those critical to the vaccine manufacturing process.
Commissioning and qualification
- Calibration Execution: Perform the actual calibration of instruments and sensors as per the approved calibration plan and industry standards. This includes temperature, pressure, flow, level, pH, conductivity, and other relevant parameters. Obtain Calibration certificate and Comprehensive records of all calibration activities, including calibration dates, adjustments made, and instrument performance data for all critical instruments, demonstrating compliance with regulatory standards and validation requirements.
- Validation, IQ, OQ, PQ Support: Collaborate with validation/C&Q team to ensure that calibrated instruments are properly integrated into the validation protocols for the manufacturing processes and equipment’s. Assist in the execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols by providing calibration records and ensuring that instruments and systems meet the specified requirements.
- Documentation and Compliance: Ensure all calibration activities are meticulously documented to demonstrate compliance with regulatory requirements (e.g., cGMP - Current Good Manufacturing Practices). Implement measures to ensure data integrity, such as secure storage of calibration data and audit trail features.
- Routine Calibration: Perform routine calibrations of critical instruments and sensors in accordance with the established calibration schedule. This includes temperature, pressure, flow, level, pH, conductivity, and any other relevant parameters. Establish a workflow to maintain instrument calibration records which include all calibration data, including pre- and post-calibration measurements, revisions performed, and calibration dates in the system, before they are release to production or testing activities.
- Scheduled Maintenance: Plan and execute scheduled maintenance activities to prevent instrument drift or failure. This may include cleaning, sensor replacement, or other preventive measures.
- Calibration Trend Analysis: Analyze calibration data over time to identify trends or deviations, allowing for proactive maintenance and calibration adjustments.
- Performing preventive and corrective actions: It is vital in maintaining the accuracy and reliability of instruments and equipment, ensuring compliance with regulatory standards, and preventing or addressing issues that may impact product quality and safety.
- Emergency Calibration: Address any emergency calibration needs promptly, especially if a critical instrument deviates from the specified range.
- Change Control: Manage calibration-related change control processes, ensuring that any changes to instruments or calibration procedures are properly documented and validated.
- Spare Parts Management: Manage spare parts inventory for instruments and sensors, ensuring that replacement components are readily available when needed.
- Calibration Training: Provide training to plant personnel on the proper use and maintenance of instruments and sensors
- Internal/External Audit: Prepare for audits by conducting thorough self-assessments and mock audits to identify and rectify any potential compliance issues in advance. During audits, the calibration engineer may serve as a subject matter expert (SME) for all calibration-related matters.
- Managing both internal calibration technicians and external service providers: Effective management of these resources ensures the reliability and performance of various type of instruments. Overseeing a team of internal calibration technicians/external service providers. This includes providing leadership, guidance, and training to ensure that technicians perform calibrations effectively and efficiently. Assign calibration tasks to internal technicians/external service providers based on workload, priority, and their individual skill sets. Ensure that calibration schedules are met.
Knowledge, Skills & Competencies / Language
- Knowledge of regulatory requirements, including FDA, EMA, HSA regulations and cGMP.
- Knowledge of relevant software tools and programming languages is beneficial.
- Proficiency in instrumentation systems, including design, installation, testing, and troubleshooting.
- Excellent verbal and written communication skills for interacting with internal teams, clients, and stakeholders.
- Strong analytical and problem-solving skills to diagnose complex technical issues and implement effective solutions.
- Familiarity with relevant industry codes, standards, and safety regulations
- Project ownership and decision-making skills
- Project scheduling & reporting skills
- Ability to lead contingent staffs, external resources, including vendors & contractors.
- Good team player willing to work for the common goal.
Qualifications / Requirement
- Related Engineering Degree from an accredited technical institution.
- Requires 10+ years of experience in in instrument calibration and maintenance, preferably in a pharmaceutical or vaccine manufacturing environment.
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