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Critical Mass Consulting

Life Sciences Technical Consultant - Portland, OR

Critical Mass Consulting, Portland, Oregon, United States, 97204


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:

Project ManagementValidation Program DevelopmentProcess Equipment QualificationCleaning / Sterilization ValidationProcess ValidationComputerized System Validation (CSV)Our company places an emphasis on continuous personal development. This includes support/financing of technical training, mentorship, and development of high performance teams.

Job Description:

Critical Mass Consulting, LLC is recruiting Consultants to join its Portland, OR field area. 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 Activities

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 AnalysesSupport multiple client sites on validation projects throughout the Portland areaWork on developing internal processes to increase quality of delivery, and increase team engagementConsult clients on latest industry approaches to commissioning, qualification and validationDevelop standards and best practices for development and validation activitiesManage medium-small teams and/or projectsAdditional 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 programsConsult clients on latest industry approaches to commissioning, qualification and validationRequired 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 FirstWe Build TogetherEmpowering Growth and Leading People to Make a DifferenceJoy and Discipline, Life in Balance

Strong interest in Life Sciences and a passion for helping othersExcellent written and verbal communication skills, emphasizing strong technical writing skillsPass the Transportation Security Administration (TSA) Security Threat Assessment (STA)Minimum 2 years of experience working in the pharmaceutical, medical device or biotech industryStrong understanding of Good Documentation Practices (GDP), and experience working in FDA regulated industriesProficiency in no-code business intelligence tools is a plus (Power BI, Tableau, etc.)