What are the responsibilities and job description for the C&Q Engineer position at United Consulting Hub?
Job Description
Job Description
Job Title : C&Q Engineer
Location : Apex, NC
Duration : 6months
Job Description :
The Commissioning and Qualification (C&Q) Specialist will play a key role in ensuring that equipment, utilities, and facilities meet regulatory and operational requirements. This position involves writing, reviewing, and executing qualification protocols and reports while working closely with cross-functional teams in a fast-paced environment.
Key Responsibilities :
Develop, review, and execute commissioning and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Ensure compliance with FDA, cGMP, and other applicable regulatory standards during C&Q activities.
Conduct system walk-downs, inspections, and testing to confirm system functionality and readiness for use.
Identify and resolve discrepancies or non-conformances in qualification activities.
Prepare detailed qualification summary reports, including deviations and resolutions.
Collaborate with project managers, engineers, and quality assurance teams to ensure seamless execution of C&Q activities.
Support risk assessments and validation planning for new and existing systems.
Maintain accurate and organized documentation to ensure traceability and compliance.
Qualifications :
Bachelor's degree in Engineering, Life Sciences, or a related field.
3 years of experience in commissioning and qualification within the pharmaceutical manufacturing industry.
Strong knowledge of FDA regulations, cGMP requirements, and industry standards.
Proficiency in writing and executing qualification documents and reports.
Excellent problem-solving skills and attention to detail.
Strong organizational and communication skills.
Ability to work independently and as part of a team in a dynamic environment.
Preferred Qualifications
Experience with specific pharmaceutical manufacturing systems or processes (e.g., cleanrooms, HVAC, sterilization, bioreactors).
Familiarity with validation lifecycle documentation.
