TCS (Triad Consulting Solutions) · 23 hours ago
CQV Engineer II / III
Athens, GA
Full-time
Onsite
Mid, Senior Level
3+ years expTriad Consulting Solutions (TCS) is a fast-growing specialty consulting firm providing engineering and CQV project management services in regulated life sciences. The CQV Engineer II or III is responsible for executing commissioning, qualification, and validation activities to ensure compliance with regulatory standards and quality requirements across client projects.
Construction
Hiring Manager
Joe Holland
Responsibilities
Manage and execute CQV deliverables across multiple concurrent projects while meeting project schedules and budget constraints
Develop, execute, and document qualification and validation activities across the full lifecycle in alignment with regulatory requirements and risk-based validation principles (e.g., ASTM E2500)
Author, review, and execute CQV documentation, including but not limited to: Design Reviews and Design Qualifications, Commissioning and Validation Plans, Risk Assessments (FMEA, impact assessments, etc.), Pre-Functional Checklists (PFCs) and Functional Test Plans (FTPs), Installation, Operational, and Performance Qualification (IQ/OQ/PQ) Protocols, Process Validation Protocols, Discrepancy Reports / Issue Logs, and Commissioning and Validation Summary Reports
Lead or support commissioning and qualification activities for GMP and non-GMP facilities, utilities, and manufacturing equipment
Routinely execute Facility, Utility, and Equipment (FUE) qualification activities within GMP manufacturing environments
Review executed protocols and test data for completeness, accuracy, and cGMP compliance; identify and resolve discrepancies in collaboration with project stakeholders
Participate in or lead project meetings with internal teams, clients, vendors, and quality representatives to communicate CQV status, risks, and mitigation strategies
Proactively identify project risks or obstacles and communicate potential impacts to timelines or compliance
Support regulatory inspections, internal audits, and client quality assessments as required
Qualification
Required
Bachelor's degree in Engineering, Chemistry, Computer Systems, or other relevant scientific discipline required; equivalent regulated industry experience may be considered
CQV Engineer II: Minimum of 3 years of hands-on CQV experience in regulated manufacturing
CQV Engineer III: Minimum of 6 years of CQV experience, including technical leadership on intermediate-to-complex projects
Demonstrated subject-matter expertise in one or more CQV disciplines: Equipment Qualification, Facility and Utilities Commissioning, Cleaning Validation, Process Validation, and/or Computer Systems Validation (CSV)
Experience using electronic or paper-based Quality Management Systems (QMS), including change control, deviation, CAPA, investigation, and document management modules
Strong working knowledge of applicable regulatory requirements and industry guidance, including: 21 CFR Parts 210, 211, and 11, ICH guidelines (Q7/Q8/Q9/Q10/Q11/Q12), ISPE Baseline Guides and GAMP, ASTM E2500, etc
Strong technical writing and documentation skills, with the ability to produce clear, compliant CQV deliverables
Effective verbal communication skills, capable of interfacing with cross-functional teams, quality organizations, and clients
Demonstrated experience in project planning, execution, and closeout
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint)
Reliable transportation is critical – job role will frequently visit clients' sites to complete project deliverables and must be able to reach the project site when requested or required
Preferred
Previous experience in pharmaceutical, biotechnology, or medical device manufacturing environments strongly preferred
Experience in sterile or aseptic manufacturing environments is highly desirable
Temperature mapping using data loggers or thermocouples
Aseptic gowning experience
Automation or control system troubleshooting
Validation of laboratory or manufacturing computerized systems
Benefits
Optimal candidates may qualify for relocation assistance, but conditions may apply.
Company
TCS (Triad Consulting Solutions)
TCS (Triad Consulting Solutions) is a full-service Construction Management, Project Management, and Commissioning, Qualification & Validation (CQV) firm headquartered in Athens, Georgia.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase