CQV Engineer II​/III

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.

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.

• 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.

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.

• Demonstrated subject‑matter expertise in one or more CQV…