Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CQV Engineers

Commissioning, Qualification, and Validation (CQV) Engineers will support execution of equipment qualification activities within a regulated biotech manufacturing environment. The scope includes executing approved protocols in Valgenesis, completing associated documentation, and generating a Validation Summary Report (VSR) for each technology type upon completion.

The engineers will ensure compliance with FDA, EMA, ICH, GMP, and client-specific quality standards, working cross-functionally with Manufacturing, Quality, Engineering, and Automation teams.

Key Responsibilities

• Execute approved Commissioning, Qualification, and Validation (CQV) protocols within Valgenesis for equipment in scope.
• Perform Installation, Operational, and Performance Qualification (IOPQ) testing for assigned systems.
• Ensure accuracy, completeness, and GDP compliance in protocol execution and data entry.
• Generate a single Validation Summary Report (VSR) for each technology type upon completion.
• Perform CTU mapping activities (Ellab or equivalent validated mapping systems).
• Support cell therapy, QC, and computerized system validation (CSV) testing where applicable.
• Collaborate with SMEs, Quality Assurance, and Validation Management to resolve deviations, discrepancies, and technical issues.
• Maintain adherence to project schedules and deliverables while ensuring compliance with regulatory requirements.

Equipment in Scope

The following equipment will require IOPQ execution and VSR generation:

• CO2 incubators
• double door refrigerators
• undercounter refrigerators
• LOVO cell washers
• NC-202 cell counters
• Multisizer cell counters

Qualifications

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or related field.
• 3–7 years of CQV experience in GMP-regulated industries (biotech/pharma preferred).
• Hands-on experience with Valgenesis electronic validation lifecycle management (ELM) system.
• Experience with CTU mapping (Ellab or equivalent system) highly preferred.
• Experience with cell therapy, QC lab equipment qualification, and/or CSV activities.
• Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
• Excellent documentation, communication, and problem-solving skills.

• CTU Mapping Specialists
  Skilled in thermal mapping, environmental monitoring, and validation of CTUs. Proficient in Ellab system for mapping and reporting, with experience qualifying incubators, refrigerators, freezers, and cryogenic systems.
• Cell Therapy/QC/CSV Specialists
  Experienced in qualification of cell therapy manufacturing equipment and QC laboratory systems. Background in computerized system validation (CSV) for GxP applications. Skilled in executing validation protocols and preparing audit-ready documentation.

Deliverables

• Execution of all assigned CQV protocols in Valgenesis.
• Completion of IOPQ execution and VSR generation for all equipment in scope.
• Complete mapping activities for defined CTUs (per project scope).
• Generate one Validation Summary Report (VSR) per technology type.
• Timely resolution of deviations and discrepancies.
• Compliance with project schedules, milestones, and quality standards.