CQV Engineer II/III

About Us

Triad Consulting Solutions (TCS) provides construction, engineering & design, and CQV project management services for capital investment initiatives. Our team specifically caters to clients in the pharmaceuticals, biotechnology, and regulated life sciences industries (USDA, FDA, EU, etc.). We are a fast-growing, specialty consulting firm that offers a flexible work environment and superior growth opportunities. Currently, TCS is looking for a motivated, self-accountable engineer with an experienced background in commissioning, qualification and validation (CQV) roles.

About the Role

The CQV Engineer II or CQV Engineer III (commensurate with experience) is responsible for executing Commissioning, Qualification, and Validation activities in support of client projects within regulated life sciences environments. This role routinely performs qualification tasks to ensure systems, facilities, utilities, equipment, and processes meet defined user requirements, quality standards, and applicable regulatory expectations.

The CQV Engineer is accountable for executing project deliverables on schedule and within budget, while maintaining compliance with cGxP principles and industry best practices. Engineers in this role are expected to work independently on clients’ sites with minimal supervision, receiving strategic guidance from the CQV Engineering Manager and TCS management team. Engineer III-level staff may serve as technical leaders on moderately complex projects and support the development of junior team members.

All TCS engineers are expected to act as ambassadors of the firm. This role includes a doer–seller component, where engineers support business development by building strong client relationships, identifying opportunities for new or expanded work, and representing the company positively through technical excellence, professionalism, and effective communication.

Key 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.

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• 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.

Optimal Candidate Requirements

Education & Experience: Bachelor’s degree in Engineering, Chemistry, Computer Systems, or other relevant scientific discipline required; equivalent regulated industry experience may be considered. Advanced degrees are a plus.

• 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.
• Previous experience in pharmaceutical, biotechnology, or medical device manufacturing environments strongly preferred.

Technical & Regulatory Expertise

• 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.
• Experience in sterile or aseptic manufacturing environments is highly desirable.

Professional Skills

• 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).

Additional Preferred Experience

• Temperature mapping using data loggers or thermocouples
• Aseptic gowning experience
• Automation or control system troubleshooting
• Validation of laboratory or manufacturing computerized systems

Further Job Details

• 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.
• Optimal candidates may qualify for relocation assistance, but conditions may apply.