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Life Science Engineer, Level 3

Boston, United States

Why Renovo?

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.

Summary

The Life Science Engineer III – Validation/Calibration & Chromatography SME is a highly skilled and technically proficient professional responsible for leading and supporting Renovo Care’s engineering service operations across a wide range of laboratory and manufacturing equipment. This hybrid role combines expertise in validation, calibration, and ISO 17025 quality systems with deep subject matter expertise in chromatography and analytical technologies.

The Engineer will oversee calibration and validation processes in GxP and ISO 17025 environments while also serving as a technical escalation point for chromatography systems, including GC, IC, SFC, LC, and LC/MS/MS. This role ensures compliance with international standards, drives service excellence, develops staff expertise, and partners cross-functionally to enhance service delivery, operational efficiency, and customer satisfaction.

What You Will Do

Validation & Calibration Responsibilities

Lead the implementation and continuous improvement of the Quality Management System (QMS) in alignment with ISO 17025
Develop and execute calibration schedules, establish metrological traceability, and document results with expanded uncertainty reporting
Design, author, and execute validation protocols (IQ/OQ/PQ) for new or modified equipment, processes, and test methods
Maintain accurate validation and calibration records to support audits and ISO accreditation
Perform planned maintenance, repair, and verification services across multi-vendor laboratory instruments (balances, centrifuges, freezers, PCRs, incubators, humidity chambers, microscopes, liquid handlers, DNA analyzers, etc.)
Train and mentor staff on calibration procedures, ISO 17025 compliance, and validation best practices

Chromatography & Service Operations Responsibilities

Act as SME for chromatography and analytical systems (LC, GC, IC, SFC, LC/MS, GC/MS, and related platforms)
Provide advanced troubleshooting and serve as the final point of escalation for service events in the field
Validate and qualify chromatography equipment, ensuring compliance with FDA, EMA, and other regulatory requirements
Develop and implement SOPs for equipment qualification and generate qualification reports
Support service pricing structures, labor hour models, and materials planning to optimize operations
Perform on-site and remote service support, planned maintenance, and hardware/software installations
Coach and mentor engineering colleagues on chromatography maintenance and repair
Communicate directly with customers to ensure service quality, provide preventive maintenance guidance, and resolve escalated issues

Cross-Functional & Continuous Improvement

Collaborate with Quality, R&D, and Service teams to resolve technical issues and support new product/service integration
Participate in internal and external audits to maintain accreditation and regulatory compliance
Drive continuous improvement initiatives in service workflows, pricing, and training

Required Education & Experience

Bachelor’s degree in Engineering, Chemistry, Biochemistry, Physics, or related scientific discipline
7+ years of experience with life science laboratory equipment in regulated environments (ISO 17025 and GxP)
5+ years of direct experience in validation, calibration, and metrology
7+ years of technical experience with chromatography systems (LC, LC/MS, GC, GC/MS, IC, SFC, etc.)

Required Skills & Competencies

Technical Expertise: Hands-on experience with calibration, validation, chromatography troubleshooting, and statistical analysis
Regulatory Knowledge: In-depth understanding of ISO 17025, ANSI/NCSL Z540, FDA/EMA requirements, and quality management systems
Problem-Solving: Strong analytical and troubleshooting skills with ability to lead root cause investigations
Communication: Clear written and verbal communication skills for reports, SOPs, training, and customer engagement
Leadership: Ability to mentor, coach, and provide SME guidance to engineers and technicians
Customer Focus: Demonstrated commitment to high service standards, relationship management, and satisfaction
Adaptability: Skilled at managing multiple priorities and responding to dynamic operational needs

Safety Requirements:

Abide and follow our Injury & Illness Prevention Program
Maintain a safe working environment for self and others if they come in contact within the biomed area in accordance with the facility’s policies
Must follow OSHA guidelines in regard to blood borne pathogens, airborne pathogens, radiation, sharp instruments and/or tools, hazardous liquids, and operating devices
Ontime completion of safety trainings assignments
Must have sensory ability to distinguish hot & cold ranges of temperature, surfaces, fine motor skills, manual dexterity, and detect/distinguish colors
Must be able be able to carry or lift up to 50 pounds routinely

Classification:

FLSA: Non-Exempt

**Note: This position description does not list every activity, duty, and responsibility of the position and may be altered by RENOVO at any time.

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