Life Science Engineer, Calibration-Validation

Renovo Solutions-posted about 21 hours ago

Full-time • Mid Level

Boston, MA

501-1,000 employees

Resume

Match Score

Upload and Match ResumeTrack Jobs with Teal

Summary: 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 quality processes to enhance efficiency and effectiveness.
Cross-Functional Collaboration: Partner with other departments, such as quality assurance and R&D, to support new product development and resolve validation-related issues.

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

Track Jobs with Teal

Job Search Resources

•

AI Resume Builder

•

Calibration Engineer Resume Examples

•

Calibration Engineer Cover Letter Examples

Life Science Engineer, Calibration-Validation

Job Search Resources

Tools

Career Hubs

Guides

Company