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Critical Mass Consulting, LLC · 3 months ago

Full Time CQV Engineer – North Carolina

Raleigh, North Carolina, United States

Full-time

Onsite

Entry, Mid Level

2+ years exp

Critical Mass Consulting, LLC is seeking a Full Time CQV Engineer to join its North Carolina field office. The role focuses on developing and executing commissioning and validation protocols while supporting life sciences clients in various quality systems and validation projects.

BiotechnologyLife ScienceProject Management

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 Raleigh Durham North Carolina 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

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

Qualification

Commissioning/Validation ProtocolsRisk AnalysesDocumentation PracticesTechnical WritingLife Sciences KnowledgeTeam ManagementCommunication Skills

Required

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