Biologics CQV Engineer - On-Floor GMP Validation

Katalyst CRO; Harvard (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

Katalyst CRO seeks hands-on CQV Engineers to support a biologics project in a GMP-regulated environment. This role is focused on executing validation protocols, working closely with manufacturing and QA/QC teams. Ideal candidates have strong experience in CQV/Validation, familiarity with process equipment, and background in biologics or biopharma. This fast-paced opportunity will involve executing IQ/OQ protocols, supporting SIP/CIP cycles, and documenting activities in ValGenesis.

Qualifications

• Strong experience in CQV / Validation (IQ/OQ).
• Hands-on experience with process equipment validation.
• Familiarity with GMP & GDP practices.

Responsibilities

• Execute IQ/OQ protocols for process equipment.
• Perform equipment walkdowns and verify against design.
• Support SIP/CIP cycles, wet testing, and temperature mapping.

Skills

CQV / Validation

Equipment validation

GMP practices

Collaboration with QA/QC

Education

Background in biologics / biopharma / cell culture

Job description

Katalyst CRO seeks hands-on CQV Engineers to support a biologics project in a GMP-regulated environment. This role is focused on executing validation protocols, working closely with manufacturing and QA/QC teams. Ideal candidates have strong experience in CQV/Validation, familiarity with process equipment, and background in biologics or biopharma. This fast-paced opportunity will involve executing IQ/OQ protocols, supporting SIP/CIP cycles, and documenting activities in ValGenesis.