Katalyst CRO

Validation Engineer III

2 months ago

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Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Perform, oversee, and guide supplier process validations (IQ/OQ/PQ) for sterile barrier packaging material manufacturing processes.
Ensure supplier process validation requirements (CTQs, drawings, specifications, risk levels, and protocols) are communicated, understood, and executed.
Collaborate with suppliers to review and approve validation documentation, including protocols and reports.
Provide hands-on support to suppliers during validation activities, ensuring compliance with regulatory standards (FDA, ISO 13485).
Lead technical discussions with suppliers to address validation challenges and resolve issues.
Coordinate post-design verification activities, including updates to engineering drawings to reflect CTQs and associated risk levels.
Deliver progress updates to internal stakeholders, ensuring alignment with program timelines and quality standards.
Conduct focused process audits, where necessary, to evaluate supplier compliance with validation protocols.

Requirements:

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.
Degree in Mechanical, Industrial Engineering or Sciences disciplines.
8+ years of experience in process validation (IQ/OQ/PQ) within a regulated industry, preferably medical devices or pharmaceuticals.
Strong understanding of sterile barrier packaging materials and associated manufacturing processes.
Proficiency in FDA, ISO 13485, ISO 11607, and other applicable regulatory standards.
Demonstrated ability to work collaboratively with suppliers and cross-functional teams.
Strong analytical skills and experience using data to drive validation decisions.
Experience with technical drawings, CTQs, and risk management principles.