What are the responsibilities and job description for the Full Time CQV Engineer – North Carolina position at Critical Mass Consulting?
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
- Risk Assessments
- Process Equipment Qualification
- Cleaning / Sterilization Validation
- 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.
Job Description:
Critical Mass Consulting, LLC is recruiting a Full Time CQV Engineer to join its North Carolina 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 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 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
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