What are the responsibilities and job description for the Calibration/Validation Specialist position at Rees Scientific Corporati?
Job Summary:
The Calibration / Validation Specialist is responsible for the installation, calibration, and validation of Rees monitoring systems and Controlled Temperature Units (CTUs), including refrigerators, freezers, clean rooms, and warehouses. Calibration duties involve ensuring equipment meets industry standards through accurate calibration and temperature mapping, focusing on maintaining proper system functionality. Validation responsibilities include confirming that systems comply with regulatory standards, performing validation protocols, and ensuring equipment operates within defined parameters. The role also involves managing and optimizing Environmental Monitoring Systems (EMS), which provide real-time data collection and alerts for critical environmental conditions such as temperature and humidity. The specialist may focus on either calibration or validation, depending on expertise, but is expected to support both functions as necessary to maintain regulatory compliance and system performance at customer sites within healthcare and life sciences environments.
Key Responsibilities:
Calibration and Validation:
- Calibrate Rees monitoring systems and various types of temperature sensors (e.g., thermocouples, RTDs, and infrared sensors) to achieve precision and compliance with industry regulations.
- Perform comprehensive system validation to ensure proper operation within established regulatory frameworks, confirming that monitoring systems accurately reflect environmental conditions.
- Execute verification procedures such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate system performance and functionality.
Routine Maintenance and Repair:
- Provide proactive and regular calibration maintenance for Rees monitoring systems to ensure ongoing monitoring accuracy, reliability, and compliance with applicable regulatory standards.
- Implement a systematic maintenance schedule that includes routine checks, adjustments, and verifications to mitigate potential issues before they affect system performance.
- Diagnose complex system malfunctions through comprehensive analysis of monitoring data and system diagnostics, applying advanced troubleshooting methodologies to identify root causes effectively.
- Develop and execute corrective action plans to address identified issues, performing necessary repairs on-site or remotely to minimize system downtime and ensure continuous operation.
- Collaborate with cross-functional teams to resolve persistent challenges, leveraging technical expertise to optimize system performance and reliability.
- Maintain meticulous records of all calibration and validation activities, ensuring comprehensive documentation for audit compliance and regulatory review.
- Utilize tracking systems to log maintenance actions, calibration results, and repair histories, fostering transparency and accountability in all operational processes.
- Regularly review and update standard operating procedures (SOPs) related to maintenance and calibration to reflect best practices and changes in regulatory requirements.
Installation:
- Coordinate and manage the installation of IT networks, positioning of sensors, configuration of software, and integration of Rees monitoring systems within healthcare and life sciences facilities.
- Collaborate with project stakeholders to define installation timelines, establish project milestones, and ensure alignment with client requirements and regulatory standards.
- Conduct thorough inspections to ensure all components are installed correctly, functioning optimally, and effectively supporting operational efficiency.
- Provide on-site leadership during installation processes, ensuring adherence to best practices and safety protocols to minimize disruptions to ongoing operations.
- Oversee project schedules and resource allocation, ensuring timely completion of installation tasks while maintaining high-quality standards.
- Facilitate communication between cross-functional teams, clients, and vendors to address potential challenges, align expectations, and resolve issues promptly.
- Document installation processes and outcomes, creating detailed reports that support compliance and provide a reference for future maintenance activities
Controlled Environments (CTUs, Clean Rooms, Warehouses):
Calibration and Validation:
- Execute precise calibration and validation procedures for Controlled Temperature Units (CTUs), including refrigerators, freezers, clean rooms, and warehouses, ensuring adherence to industry standards and regulatory compliance.
- Implement systematic calibration processes for various sensor types, such as thermocouples, RTDs, and data loggers, to maintain accuracy in temperature measurements critical to product integrity.
- Conduct extensive temperature mapping studies to evaluate and ensure temperature consistency and stability throughout controlled environments, identifying hotspots and cold spots that may affect stored products.
- Utilize advanced temperature mapping techniques, including the placement of multiple data loggers over designated periods, to create comprehensive temperature profiles that guide facility design and operational procedures.
- Validate environmental conditions to meet and exceed standards such as ISO 9001, ISO/IEC 17025, GxP, and FDA, ensuring that all equipment and processes conform to established guidelines for quality management and operational excellence.
- Prepare detailed documentation of validation processes, including protocols, results, and corrective actions, to support audits and inspections by regulatory bodies.
- Collaborate with facility management to implement ongoing monitoring solutions that track environmental conditions in real-time, facilitating prompt responses to any deviations from established parameters.
- Recommend and execute adjustments to systems and protocols based on validation results and ongoing assessments to enhance operational efficiency and compliance.
- Willingness to travel to customer sites as required, which may include overnight stays
Key Qualifications:
Education:
- Bachelor’s degree in Engineering, Biology, Chemistry, or a related field; advanced degrees or certifications in calibration and validation are a plus.
- Professional certification in calibration, validation, or related quality assurance standards (e.g., ASQ, ISO 9001) is highly desirable.
Experience:
- Minimum of 3-5 years of experience in calibration and validation within healthcare, life sciences, or regulated environments.
- Proven experience in operating and maintaining Environmental Monitoring Systems (EMS) and Controlled Temperature Units (CTUs).
- Demonstrated expertise in performing temperature mapping studies and adhering to regulatory standards such as ISO/IEC 17025, GxP, and FDA.
Skills:
- Strong understanding of calibration methods, temperature sensors (RTDs, thermocouples, data loggers), and related technologies.
- Ability to analyze complex data sets to identify trends, anomalies, and areas for improvement in monitoring systems.
- Proficient in coordinating multiple projects simultaneously, managing timelines, and delivering results within deadlines.
- Excellent problem-solving skills with a methodical approach to diagnosing and resolving system malfunctions.
- Strong organizational skills with meticulous attention to detail in maintaining records of calibration and validation activities.
- Exceptional verbal and written communication skills to effectively interact with cross-functional teams, clients, and regulatory bodies.
Personal Attributes:
- Demonstrates a strong focus on accuracy and precision, ensuring compliance with industry standards.
- Takes initiative and possesses the ability to work independently with minimal supervision, driving projects to successful completion.
- Comfortable working in dynamic environments and able to adjust to changing priorities and requirements.
- Collaborates effectively with colleagues across various departments, fostering a positive work environment and achieving common goals.
- Passionate about maintaining high-quality standards and continuously improving processes to enhance operational efficiency
What We Offer:
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A collaborative work environment.
Equal Employment Opportunity: Rees Scientific is an equal opportunity employer.
