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Katalyst CRO · 11 hours ago

Validation Engineer

Holly Springs, NC

Contract

Onsite

Senior Level

Katalyst CRO is a company focused on drug substance manufacturing, seeking a Senior CQV Engineer. This role involves leading commissioning, qualification, and validation activities for Clean-In-Place systems, ensuring compliance with regulatory standards while collaborating with cross-functional teams.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations

Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities

Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports

Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions

Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria

Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing

Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria

Support residue, bioburden, and TOC sampling strategies as part of cleaning validation

Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations

Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance

Provide validation support during tech transfers, process changes, and new equipment installations

Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements

Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation

Support internal and external audits and regulatory inspections

Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams

Provide guidance and mentoring to junior CQV engineers and validation resources as needed

Qualification

CIP systemsCleaning validationGMP complianceValidation protocolsRisk assessmentsCross-functional collaborationTechnical mentoring

Required

Hands-on experience in CIP system design review, qualification execution, and cleaning validation strategy

Ability to work independently in a fast-paced manufacturing environment

Collaboration skills with Engineering, Manufacturing, Quality, and Automation teams

Lead and execute commissioning, qualification, and validation activities for CIP systems