Life Science Engineer, Calibration-Validation

Renovo Solutions is a nationwide healthcare technology management company. We offer a range of opportunities for technicians to grow within the company. With a presence in 40+ states, we provide comprehensive solutions for managing & maintaining healthcare technologies. We prioritize investing in our employees' development, offering various phases and advancement paths. Through ongoing training, mentorship programs, and a supportive work environment, we foster professional growth and promote from within.

Join our team to make a difference in healthcare while advancing your career with Renovo.

A Life Science Engineer III – Validation/Calibration Engineer SME is a highly skilled and technically proficient professional responsible for leading and supporting Renovo Care’s engineering service operations. performs and documents scheduled maintenance and repair services on research and manufacturing equipment at pharmaceutical facilities and GxP environments. They will be responsible for developing, executing, and reporting on validation activities for testing and calibration methods, equipment, and software in an ISO 17025 accredited laboratory.

This role requires a strong understanding of quality management systems and a meticulous approach to documentation and problem-solving to ensure full compliance with international standards and regulatory requirements.

Responsibilities also include preventative maintenance, calibration, and validation of equipment ranging from devices such as water purification, scales/ balances, centrifuges, freezers/LN2 storage units/refrigerators, incubators, and humidity chambers, PCRs, thermocyclers, microscopes, liquid handlers, DNA analyzers, or equivalent instruments.

QMS Development and Expansion:
Oversee the implementation and continuous improvement of the QMS to meet ISO 17025 requirements, focusing on areas for growth and new calibration services.

Calibration Expertise:
Develop and implement calibration schedules, establish metrological traceability, and ensure the accurate documentation of calibration results and certificates, including expanded uncertainty.

Technical Leadership:
Provide subject matter expertise to technical teams, troubleshoot calibration-related issues, and contribute to the design and validation of new calibration processes.

Staff Development:
Train and mentor laboratory personnel on ISO 17025 procedures, calibration techniques, and quality standards.

Equipment Management:
Oversee the maintenance, calibration, and verification of precision test equipment, ensuring it is properly labeled, and its status is clearly identifiable. Performs planned maintenance, repairs, and other verification/qualification services on a variety of laboratory multi-vendor instruments. Installs and optimizes hardware/software/network products and configurations at customer sites. Provides accurate and timely completion of service reports, expense reports and other administrative tasks

Protocol Development:
Design, author, and review validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for new or modified equipment, processes, and test methods.

Execution and Reporting:
Execute validation studies according to approved protocols and write comprehensive final reports that summarize results and confirm compliance with acceptance criteria.

Documentation Management:
Maintain accurate and complete validation records, test results, and other quality documentation in accordance with ISO 17025 standards.

Accreditation Support:
Assist the Quality or Lab Manager in preparing for and participating in internal and external audits to maintain ISO 17025 accreditation.

Compliance and Regulation:
Stay up-to-date on ISO 17025 requirements, industry regulations, and best practices, and ensure all validation activities are in full compliance.

Issue Resolution:
Lead or assist in root cause analysis and corrective action planning for any deviations or non-conformances identified during validation or testing.

Continuous Improvement:
Drive continuous improvement in testing methodologies and…