CSV & CQV Specialist - GMP Systems Validation Leader

JC Automation

Gurabo (PR)

On-site

USD 85,000 - 110,000

Full time

9 hours ago

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Job summary

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

You will author validation deliverables, lead change control activities, and support commissioning and equipment qualification. The role requires strong regulatory knowledge, rigorous documentation discipline, data integrity (ALCOA++), and the ability to work independently within a established quality system across facilities and utilities, with

Qualifications

Bachelor's degree in Engineering, Life Sciences, or a related discipline.
2–4 years of CSV or CQV experience in pharma GMP environments.
Experience with URS, Design Specs, IQ/OQ/PQ, and Traceability Matrix.
Experience presenting change controls within a pharmaceutical quality system.
Data Integrity knowledge and ALCOA++.
Bilingual in English and Spanish (oral and written).

Responsibilities

Participate in team meetings to align on timeline, tasks, and status.
Execute CSV and CQV activities for computerized systems, facilities, and utilities.
Support commissioning and qualification for GMP facilities and utilities.
Develop and revise procedures to meet regulatory expectations.
Lead change control activities and present to the Change Control Board.
Assist external connectivity validation as needed.