Renovo Solutions · 2 months ago
Life Science Engineer, Calibration-Validation
Boston, MA
Full-time
Onsite
Senior Level
7+ years expRenovo Solutions is a nationwide healthcare technology management company that offers a range of opportunities for technicians to grow within the company. The Life Science Engineer III – Validation/Calibration Engineer SME is responsible for leading and supporting engineering service operations, focusing on the validation and calibration of equipment in pharmaceutical facilities and GxP environments.
Health Care
Responsibilities
Oversee the implementation and continuous improvement of the QMS to meet ISO 17025 requirements, focusing on areas for growth and new calibration services
Develop and implement calibration schedules, establish metrological traceability, and ensure the accurate documentation of calibration results and certificates, including expanded uncertainty
Provide subject matter expertise to technical teams, troubleshoot calibration-related issues, and contribute to the design and validation of new calibration processes
Train and mentor laboratory personnel on ISO 17025 procedures, calibration techniques, and quality standards
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
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
Execute validation studies according to approved protocols and write comprehensive final reports that summarize results and confirm compliance with acceptance criteria
Maintain accurate and complete validation records, test results, and other quality documentation in accordance with ISO 17025 standards
Assist the Quality or Lab Manager in preparing for and participating in internal and external audits to maintain ISO 17025 accreditation
Stay up-to-date on ISO 17025 requirements, industry regulations, and best practices, and ensure all validation activities are in full compliance
Lead or assist in root cause analysis and corrective action planning for any deviations or non-conformances identified during validation or testing
Drive continuous improvement in testing methodologies and quality processes to enhance efficiency and effectiveness
Partner with other departments, such as quality assurance and R&D, to support new product development and resolve validation-related issues
Qualification
Required
Bachelor's degree in Engineering (Mechanical, Electrical, or related field) or a relevant science discipline
Minimum 7 years of experience in a regulated environment, preferably an ISO 17025 accredited testing or calibration laboratory
Minimum 3 years in GxP or Validation environment
In-depth knowledge of the ISO/IEC 17025 standard is essential. Significant experience in a related field, such as metrology or calibration, with a strong focus on ISO 17025 compliance
Experience with regulatory requirements and quality management systems
Demonstrated ability to write and execute detailed technical protocols and reports
Excellent analytical, problem-solving, and troubleshooting skills
Technical expertise: Hands-on experience with test equipment, calibration, data acquisition, and statistical analysis. In-depth understanding of calibration principles, standards (e.g., ISO 17025, ANSI/NCSL Z540), metrology, measurement uncertainty, and relevant software tools
Attention to detail: Meticulous documentation and a thorough approach to testing and compliance
Communication: Strong verbal and written communication skills for authoring reports and interacting with internal and external stakeholders
Problem-solving: Ability to identify issues, conduct root cause analysis, and implement effective solutions
Adaptability: Capacity to manage multiple projects and respond to changing priorities in a dynamic environment
Accountability – takes ownership of assigned work and responsibilities, follows through, and closes the loop
Communication – clearly expresses thoughts and ideas both in written and verbal communications, provides timely information
Financial Acumen – Considers financial impact of all decisions
Integrity – Can admit mistakes, is direct and truthful
Customer Service – demonstrates a 'customer-first' mentality, focused on meeting the needs of customers and captures feedback to make improvements
Priority Setting – Prioritizes assigned schedules and workload
Team Building – Mentors newer technicians, facilitates clear communication amongst the team, demonstrates care and respect for co-workers and colleagues
Giving Feedback – Provides constructive feedback towards department goals and activities, helps to foster growth within the team
Abide and follow our Injury & Illness Prevention Program
Maintain a safe working environment for self and others if they come in contact within the laboratory 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
On-time completion of safety trainings assignments
Company
Renovo Solutions
Renovo solutions provides coverage and services to hospitals and healthcare facilities across the united states.
501-1000 employees
H1B Sponsorship
Renovo Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Water Street Healthcare Partners
2022-01-11Private Equity
Leadership Team
Bill Newell
Chief Executive Officer
Joseph Happ
Co-Founder
Recent News
2025-09-12
2022-01-13
2022-01-12
Company data provided by crunchbase