CQV Engineer

Shoolin Inc; Indiana (PA); On-site; USD 80,000 - 110,000; Full time

Job summary

Shoolin Inc is looking for a skilled CQV Engineer to support commissioning, qualification, and validation activities in Indiana, US. The role focuses on ensuring compliance with regulatory standards in the pharma and medical device sectors. Key responsibilities include executing CQV activities, developing validation documentation, and coordinating with various teams. Candidates should have 3–10 years of experience in CQV/Validation and a Bachelor’s degree in Engineering. Familiarity with GMP is a must.

Qualifications

• 3–10+ years of experience in CQV/Validation within pharma, biotech, or medical device industries.
• Strong understanding of GMP (Good Manufacturing Practices).
• Experience with validation of HVAC, WFI, Clean Steam, and Compressed Air.

Responsibilities

• Execute CQV activities for manufacturing equipment and facility systems.
• Develop and review validation documentation including URS and FS.
• Support FAT and SAT activities.
• Coordinate with cross‑functional teams including Engineering and Quality Assurance.
• Ensure compliance with FDA and EU GMP regulations.

Skills

GMP (Good Manufacturing Practices)

Risk assessments (e.g., FMEA)

Validation protocols

Stakeholder management

Education

Bachelor’s degree in Engineering

Tools

PLC/SCADA

Job description

Job Title: CQV Engineer (Commissioning, Qualification & Validation)

Experience Required: 5 –10 Years

Job Summary

We are seeking a skilled CQV Engineer to support commissioning, qualification, and validation activities for equipment, utilities, and facilities in regulated environments such as pharmaceuticals, biologics, or medical devices. The role involves ensuring systems are installed, tested, and operated in compliance with regulatory standards and company quality requirements.

Key Responsibilities

• Execute Commissioning, Qualification, and Validation (CQV) activities for manufacturing equipment, clean utilities, and facility systems.
• Develop and review validation documentation including:
  • User Requirement Specifications (URS)
  • Functional Specifications (FS)
  • Design Qualification (DQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Support FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) activities.
• Coordinate with cross‑functional teams including Engineering, Quality Assurance, and Operations.
• Ensure compliance with regulatory standards such as:
  • FDA (21 CFR Part 11, Part 210/211)
  • EU GMP
  • GAMP 5 guidelines
• Perform risk assessments (e.g., FMEA) and impact assessments for system changes.
• Support validation lifecycle management and change control processes.
• Troubleshoot equipment and systems during qualification phases.
• Maintain accurate documentation and ensure audit readiness.

Required Qualifications

• Bachelor’s degree in Engineering (Chemical, Mechanical, Electrical, or related field).
• 3–10+ years of experience in CQV/Validation within pharma, biotech, or medical device industries.
• Strong understanding of GMP (Good Manufacturing Practices).
• Experience with validation of:
  • Utilities (HVAC, WFI, Clean Steam, Compressed Air)
• Familiarity with documentation standards and validation protocols.

Preferred Qualifications

• Experience in biologics, sterile manufacturing, or aseptic processes.
• Knowledge of automation systems (PLC/SCADA).
• Certification or training in validation or quality systems.
• Strong communication and stakeholder management skills.