CQV Engineer

Critical Mass Consulting, LLC is seeking individuals who want to learn and develop within a dynamic, start-up environment. We believe in our purpose: To develop a company which thrives on connectivity and engagement; to build a premier consulting organization, which rewards creativity, contribution, and growth. Critical Mass Consulting, LLC is supporting Life Sciences clients in the areas of: Validation Program Development Periodic Reviews Process Equipment Qualification Process Validation Computerized Systems Validation Our company places an emphasis on continuous personal development. This includes support/financing of technical training, mentorship, and development of high performance teams. Role & Responsibilities Critical Mass Consulting, LLC is recruiting a Full Time CQV Engineer to join its San Diego field office. If you have a passion for Life Sciences and helping others, we are interested in discussing our company, our process and what it means to join our team-focused organization. Expected Responsibilities Develop and execute commissioning/validation protocols, such as factory and site acceptance test (FAT, SAT), installation, operational and performance qualifications (IQ/OQ/PQ) on various critical systems, process equipment and supporting processes. Develop and perform Risk Analyses Support multiple client sites on validation projects in the San Diego area Work on developing internal processes to increase quality of delivery, and increase team engagement Consult clients on latest industry approaches to commissioning, qualification and validation Develop standards and best practices for development and validation activities Manage medium-small teams and/or projects Additional Responsibilities Participate in team-based projects, supporting life sciences clients in the areas of Quality Systems and Validation Establish or maintain quality systems, including Change Control, Deviations, and CAPAs programs Consult clients on latest industry approaches to commissioning, qualification and validation Required Qualifications Belief in our Core Values. These 4 values provide the foundation for how we operate as a company. With these common shared values, we can effectively accomplish our mission of organizational excellence. People Come First We Build Together Empowering Growth and Leading People to Make a Difference Joy and Discipline, Life in Balance Strong interest in Life Sciences and a passion for helping others Excellent written and verbal communication skills, emphasizing strong technical writing skills Minimum 2 years of technical experience working in the pharmaceutical, medical device or biotech industry Strong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industries #J-18808-Ljbffr Critical Mass Consulting, LLC