The Validation Specialist is responsible for supporting qualification and validation activities for manufacturing equipment and processes. The role focuses on the execution of IQ, OQ, and PQ protocols, development and maintenance of SOPs, risk management activities such as PFMEA, and cleaning validation. This position ensures compliance with applicable regulatory requirements and internal quality standards across multiple manufacturing machines and systems.
Key Responsibilities
-
Execute and document equipment qualification activities, including
Installation Qualification (IQ)
,
Operational Qualification (OQ)
, and
Performance Qualification (PQ)
for manufacturing equipment and systems.
-
Develop, review, update, and maintain
Standard Operating Procedures (SOPs)
related to validation, equipment operation, and cleaning processes.
-
Lead or support
Process Failure Modes and Effects Analysis (PFMEA)
and other risk assessment activities for new and existing equipment.
-
Perform and support
Cleaning Validation
studies, including protocol development, execution, sampling, and final reports.
-
Experience conducting or supporting
PFMEA
and risk management activities.
-
Knowledge of
Cleaning Validation
principles and execution.
-
Experience working with different types of
manufacturing equipment and/or machinery
.
-
Familiarity with GMP regulations and FDA guidelines.
Requirements
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Bachelor’s degree in Engineering, Life Sciences, or a related field.
-
Bilingual (Spanish/English)
-
Computer literacy
