CQV Specialist: Sterilization & SIP Expert

Veg Group

Juncos (PR)

On-site

USD 90,000 - 120,000

Full time

6 days ago

Be an early applicant

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Validation & Engineering Group, Inc. in Puerto Rico seeks an experienced CQV Specialist – Sterilization / SIP to support sterilization qualification activities as part of a biologics drug-substance project in an existing GMP facility in Juncos.

You will develop and execute sterilization qualification protocols, including SIP and autoclave studies, review procedures, coordinate instrumentation, and contribute to final reports while collaborating with Manufacturing, QC, EHS and Quality teams.

Qualifications

Bachelor's degree in Engineering, Science, Microbiology, Biotechnology, or related field.
CQV or validation experience within a GMP pharmaceutical or biotechnology facility.
Experience with SIP and/or autoclave qualification.
Knowledge of thermometric qualification methodologies.
Experience using biological indicators during sterilization studies.
Understanding of sterilization-cycle parameters and lethality concepts.
Experience generating and executing protocols and preparing final reports.
Strong GMP documentation and technical-writing capabilities.

Responsibilities

Develop and execute sterilization qualification protocols.
Support SIP qualification activities for upstream and downstream manufacturing systems.
Support qualification of new or impacted autoclave cycles and loads where applicable.
Review system design, sequence of operations, operational parameters, manufacturing procedures, equipment documentation, and associated recipes.
Identify critical and non-critical sterilization parameters.
Support thermometric qualification studies.
Prepare and handle biological indicators as required by approved protocols.
Coordinate instrumentation, thermocouples, equipment availability, and execution logistics.
Coordinate activities with Manufacturing, Engineering, QC, EHS, Quality, and CQV personnel.
Evaluate sterilization-cycle process data including temperature profiles, exposure times, lethality, flow and process conditions.
Generate and evaluate PI Historian / PI ProcessBook trend charts.
Analyze cycle data against protocol acceptance criteria by the end of the applicable working shift.
Support sterilization Conditional Release activities.
Immediately identify and communicate unexpected results or protocol discrepancies.
Support technical investigations, deviations, and corrective actions.
Prepare and route sterilization qualification reports for review and approval.
Participate in peer review of calculations and technical data.
Support night, weekend, or continuous manufacturing schedules when required.