GMP CSV & CQV Specialist - Pharma Validation

JC Automation Corp.; Gurabo, Northern (PR, KY); Hybrid; USD 80,000 - 120,000; Full time

Job summary

JC Automation Corp. seeks experienced CSV/CQV professionals to support a high-priority automation program in a cGMP pharmaceutical manufacturing environment.

You will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and support commissioning and equipment qualification. Responsibilities include validating computerized systems, facilities, and utilities; developing SOPs; and collaborating with cross-functional teams to ensure

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 2–4 years of CSV or CQV experience in pharma/biotech GMP environments.
• Experience with full CSV lifecycle docs: URS, Design Specs, IQ/OQ/PQ, Traceability Matrix, Risk Assessment, Summary Reports.
• Experience presenting change controls in a pharmaceutical quality system.
• Working knowledge of Data Integrity principles and ALCOA++.

Responsibilities

• Actively participate in project team meetings to discuss timelines, activities, escalations, and task status.
• Execute CSV and CQV activities for computerized systems, facilities, and utilities, including related IQ/OQ/PQ documentation.
• Support commissioning/qualification activities for GMP facilities and utilities and oversee related documentation.
• Develop and revise controlled procedures to meet regulatory expectations and site quality systems.
• Perform Data Integrity assessments and assist remediation for computerized systems.
• Lead change control meetings and prepare change documentation for validation and equipment qualification.

Skills

CSV/CQV Execution

Data Integrity

ALCOA++ Knowledge

Bilingual English/Spanish

Team Participation

Education

Bachelor's degree in Engineering or related field (Computer, Electrical, Mechanical, Chemical)

Job description

JC Automation Corp. seeks experienced CSV/CQV professionals to support a high-priority automation program in a cGMP pharmaceutical manufacturing environment.

You will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and support commissioning and equipment qualification. Responsibilities include validating computerized systems, facilities, and utilities; developing SOPs; and collaborating with cross-functional teams to ensure