CSV & CQV

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. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

We are seeking experienced Computer System Validation (CSV) and Commissioning, Qualification & Validation (CQV) professionals to support a high-priority automation and computerized systems program within a cGMP pharmaceutical manufacturing environment. Resources will contribute to the full validation and qualification lifecycle for critical manufacturing systems.In this role, you will author and execute validation deliverables, lead change control activities, perform Data Integrity assessments, and support commissioning and equipment qualification. Strong regulatory knowledge, excellent documentation discipline, and the ability to work independently within an established quality system are essential.

RESPONSIBILITIES

• Team Participation:Actively participate in team meetings to provide input on project timeline considerations, activities, escalations, and status of assigned tasks.
• CSV & CQV Execution: Execute Computer System Validation and Commissioning & Qualification activities for computerized systems, equipment, facilities, and utilities, including commissioning support and qualification activities such as Validation Plans, Security Plans, Administration and Operational SOPs, Installation and Operational Verification, Test Summaries, Risk Assessments, Master Document Lists, Traceability Matrices, Disaster Recovery Plans, Business Continuity Plans, Performance Qualification, System Inventory Lists, Source Code Reviews, User Requirements, and Design Specifications.
• Facilities & Utilities Commissioning: Support commissioning and qualification activities for GMP facilities and utilities, including installation verification, functional testing, system turnover, punch list resolution, and applicable IQ/OQ/PQ documentation.
• Procedure Development: Develop and revise controlled procedures in alignment with current regulatory expectations and site quality systems.
• Data Integrity: Perform Data Integrity assessments and support remediation activities for computerized systems.
• Change Control: Lead change control meetings, generate change control documentation for computer system validation and equipment qualifications, and present changes to the Change Control Review Board.
• External Connectivity: Support external system connectivity installation and operational verification.

REQUIREMENTS & QUALIFICATIONS

Required

• Bachelor's degree in Engineering (Computer, Electrical, Mechanical, Chemical), Life Sciences, or a related technical discipline.
• Minimum 2–4 years of experience authoring and executing CSV or CQV deliverables in a pharmaceutical or biotech GMP environment.
• Demonstrated experience with full CSV lifecycle documentation — URS, Design Specs, IQ/OQ/PQ, Traceability Matrix, Risk Assessment, Summary Reports.
• Experience generating and presenting change controls in a formal pharmaceutical quality system.
• Working knowledge of Data Integrity principles and ALCOA++.
• Bilingual in English and Spanish (oral and written)