CQV Engineer
Shoolin Inc, Indiana, PA, United States
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.
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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.
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