CQV Engineer — Pharma Validation & Compliance Leader

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

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.